ClinicalTrials.gov record NCT04223765

Study of Kappa Chimeric Antigen Receptor (CAR) T Lymphocytes Co-Expressing the Kappa and CD28 CARs for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Phase 1 Study of the Administration of T Lymphocytes Expressing the Kappa Chimeric Antigen Receptor (CAR) and CD28 Endodomain for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1 trial studies engineered (autologous) T cells that target the kappa light chain in people with kappa-positive indolent non-Hodgkin lymphomas and mantle cell lymphoma. After collecting a participant's T cells (blood draw or leukapheresis), patients receive short-course chemotherapy to reduce immune cells and then a single infusion of the modified CAR T cells in a dose-escalation plan. The study watches for side effects, measures how long the CAR T cells persist, and collects early information on tumor response with long-term follow-up.

What it is studying. The study is testing autologous T cells engineered to express a kappa-directed chimeric antigen receptor with a CD28 signaling domain (called CAR.κ.28). It aims to find a safe and tolerable dose, describe side effects, measure how long the modified cells remain in the blood, and gather early data on effects against lymphoma.

What the researchers hope to learn. Scientific goals are to determine the safety and tolerability of CAR.κ.28 cells, identify a recommended phase 2 dose (RP2D), document adverse events using standard grading (including ICANS and CRS grading), assess progression-free survival, overall survival, objective response rate and duration of response, and explore persistence of the CAR.κ.28 cells in peripheral blood.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This study will combine both T cells and antibodies in order to create a more effective treatment. The treatment tested in this study uses modified T-cells called Autologous T Lymphocyte Chimeric Antigen Receptor (ATLCAR) cells targeted against the kappa light chain antibody on cancer cells. For this study, the anti-kappa light chain antibody has been changed so instead of floating free in the blood, a part of it is now joined to the T cells. Only the part of the antibody that sticks to the lymphoma cells is attached to the T cells. When an antibody is joined to a T cell in this way, it is called a chimeric receptor. The kappa light chain chimeric (combination) receptor-activated T cells are called ATLCAR.κ.28 cells. These cells may be able to destroy lymphoma cancer cells. They do not, however, last very long in the body so their chances of fighting the cancer are unknown. Previous studies have shown that a new gene can be put into T cells to increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes make up the chemical structure carrying your genetic information that may determine human characteristics (i.e., eye color, height and sex). The new gene that is put in the T cells in this study makes an antibody called an anti-kappa light chain. This anti-kappa light chain antibody usually floats around in the blood. The antibody can detect and stick to cancer cells called lymphoma cells because they have a substance on the outside of the cells called kappa light chains. The purpose of this study is to determine whether receiving the ATLCAR.κ.28 cells is safe and tolerable and learn more about the side effects and how effective these cells are in fighting lymphoma. Initially, the study doctors will test different doses of the ATLCAR.κ.28, to see which dose is safer for use in lymphoma patients. Once a safe dose is identified, the study team will administer this dose to more patients, to learn about how these cells affect lymphoma cancer cells and identify other side effects they might have on the body. This is the first time ATLCAR.κ.28 cells are given to patients with lymphoma. The Food and Drug Administration (FDA), has not approved giving ATLCAR.κ.28 as treatment for lymphoma. This is the first step in determining whether giving ATLCAR.κ.28 to others with lymphoma in the future will help them.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • CAR.k.28
  • Fludarabine
  • Cyclophosphamide
  • Bendamustine

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Note: During the period of cell procurement and CAR.κ.28 T cell production, subjects are allowed to receive additional standard of care chemotherapy to stabilize their disease if the treating physician feels it is in the subject's best interest. For subjects requiring bridging chemotherapy while awaiting manufacture of their CAR.κ.28 T-cells, details regarding treatment(s) administered including dose, frequency, number of cycles, etc. will be collected.
  • Inclusion Criteria for the Study
  • Unless otherwise noted, subjects must meet all of the following criteria to participate in this study:
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Adults ≥18 years of age.
  • Diagnosis of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma OR histologically confirmed B-cell NHL, including the following types defined by WHO 2016:
  • Aggressive Lymphomas:
  • DLBCL not otherwise specified (NOS)
  • T cell/histiocyte rich large B cell lymphoma; primary cutaneous DLBCL, leg type; EBV-positive DLBCL NOS; DLBCL associated with chronic inflammation; Lymphomatoid granulomatosis; Large B-cell lymphoma with IRF4 rearrangement; Intravascular large B-cell lymphoma; ALK-positive large B-cell lymphoma
  • Primary mediastinal (thymic) large B-cell lymphoma
  • High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; high grade B-cell lymphoma, NOS
  • B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
  • Transformation of indolent lymphoma or CLL to DLBCL will also be included
  • Burkitt lymphoma
  • Indolent Lymphomas:
  • Follicular lymphoma grade 1-3b
  • Splenic marginal zone lymphoma
  • Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue
  • Nodal marginal zone lymphoma
  • Mantle cell lymphoma
  • Subjects with central nervous system (CNS) disease will not be excluded as long as it has been stable for 3 months
  • Subjects with bone marrow only involvement are eligible
  • Subjects relapsed after autologous or allogeneic stem cell transplant are eligible for this study.
  • Subjects who have received prior CD19-directed CAR therapies for relapsed/refractory disease are eligible for this study. However, at least 3 months must have passed since the subject received CD19 CAR-T cells.
  • Patients with aggressive lymphomas must have relapsed or refractory disease after having received at least 2 prior lines of systemic therapy, including, at a minimum:
  • An anti-CD20 monoclonal antibody
  • An anthracycline containing chemotherapy regimen (if eligible)
  • An autologous stem cell transplant (if eligible)
  • For indolent lymphomas, subjects must have received at least 2 prior lines of therapy for their lymphoma
  • Subjects with specifically relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma must have received at least 2 prior therapy regimens which can include, but not limited to:
  • A combination of an anti-CD20 monoclonal antibody and an alkylating agent, OR
  • A Bruton's Tyrosine Kinase Inhibitor, OR
  • A BCL-2 inhibitor in combination with an anti-CD20 monoclonal antibody
  • Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial at the investigator's discretion.
  • Kappa-positive expression on lymphoma or CLL/SLL tissue sample, or kappa restriction on flow cytometry (archival or fresh) as confirmed by institutional hematopathology standard (result must be confirmed at the time of cell procurement).
  • Karnofsky score of > 60%
  • Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. Female subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. The two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. Female subjects of childbearing potential will also be instructed to tell their male partners to use a condom.

Exclusion criteria

  • for the Study
  • Subjects meeting any of the following exclusion criteria will not be able to participate in this study (procurement, lymphodepletion and cell infusion):
  • A history of intolerance to bendamustine or fludarabine. Note: subjects with known history of intolerance to bendamustine may be considered for lymphodepletion with cyclophosphamide and fludarabine at the discretion of the clinical investigator.
  • 2 Subject is pregnant or lactating. 3 Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving <10 mg daily may be enrolled at discretion of investigator. 4 Active infection with HTLV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy as well as no history of HIV. Subjects are required to have negative HIV antibody, negative HTLV1 and HTLV2 antibodies, negative hepatitis B surface antigen, and negative HCV antibody or viral load.
  • Eligibility Criteria to be Met Prior to Procurement
  • Subject has signed a consent to undergo cell procurement.
  • Evidence of adequate organ function as defined by:
  • Total bilirubin <1.5 × ULN (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level >1.5 mg/dL if their conjugated bilirubin is <1.5 × ULN)
  • AST and ALT < 5x ULN
  • Pulse oximetry of >90% on room air
  • Creatinine ≤ 2 x ULN
  • Imaging results from within 120 days prior to procurement to assess presence of active disease.
  • Confirmed kappa-positive expression on lymphoma or CLL/SLL tissue or bone marrow sample (archival or fresh) as confirmed by pathology.
  • Subject has adequate cardiac function, defined as:
  • No ECG evidence of acute ischemia
  • No ECG evidence of active, clinically significant conduction system abnormalities
  • Prior to study entry, any ECG abnormality at screening not felt to put the subject at risk has to be documented by the investigator as not medically significant
  • No uncontrolled angina or severe ventricular arrhythmia
  • Left ventricular ejection fraction (LVEF) >40% as measured by ECHO, with no additional evidence of decompensated heart failure, performed within 30 days prior to procurement
  • In women of child-bearing potential, negative serum pregnancy test within 72 hours prior to procurement or documentation that the subject is post-menopausal. Post-menopausal status must be confirmed with documentation of absence of menses for > 1 year.
  • Eligibility Criteria to be Met Prior to Lymphodepletion
  • Written informed consent to enroll in the CAR-T cell therapy trial must be obtained prior to lymphodepletion.
  • The last bridging therapy should be completed at least 3 weeks prior to lymphodepletion.
  • Subjects who have received bridging therapy will be reassessed with imaging within 5 days prior to lymphodepletion and at least 3 weeks after bridging therapy. If a patient did not receive bridging chemotherapy, they will be imaged within 10 days prior to lymphodepletion.
  • Adequate organ function per the following criteria are required prior to lymphodepletion:
  • Adequate bone marrow function, as defined by:
  • ANC >1.0 × 109/L
  • Platelets >50 × 109/L unless related to lymphoma involvement (independent of transfusion within 7 days of lymphodepletion)
  • Total bilirubin ≤1.5 × ULN (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level >1.5 mg/dL if their conjugated bilirubin is <1.5× ULN)
  • AST and ALT ≤ 5× ULN
  • Pulse oximetry of > 90% on room air
  • Creatinine ≤2 x ULN
  • If subjects display any clinical signs or symptoms of cardiac dysfunction after receiving bridging chemotherapy, they will undergo repeat ECG and ECHO to reassess their cardiac function and status
  • In female subjects of childbearing potential, a negative serum pregnancy test within 72 hours prior to l ymphodepletion or documentation that the subject is post-menopausal or has been surgically sterilized.
  • Post-menopausal status must be confirmed with documentation of absence of menses for > 1 year.
  • In subjects with CLL/SLL, a bone marrow biopsy within 28 days prior to lymphodepletion.
  • In subjects with WM/LPL, a bone marrow biopsy within 90 days prior to lymphodepletion.
  • Subjects must have autologous transduced activated T-cells that meet the Certificate of Analysis (CofA) acceptance criteria.
  • Has not received any tumor vaccines within the previous six weeks prior to lymphodepletion.
  • Has not received investigational agent or cancer-directed therapy within the previous 3 weeks, or 5 half-lives (whichever is shorter), prior to lymphodepletion.
  • Subjects may not be receiving strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) up through 72 hours after the last dose of bendamustine, as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites. See http://medicine.iupui.edu/clinpharm/ddis/ for an updated list of strong inhibitors of CYP1A2
  • Subject is not taking a prohibited or contraindicated medication listed in the protocol. Contraindicated medications should be discontinued at least two weeks prior to the scheduled lymphodepletion or by at least 5 half-lives of the contraindicated medication, whichever is shorter.
  • No evidence of uncontrolled infection or sepsis.
  • Eligibility Criteria to be Met Prior to Cell Infusion After Lymphodepletion
  • No evidence of uncontrolled infection or sepsis.
  • Evidence of adequate organ function as defined by:
  • Total bilirubin ≤2 × ULN, unless attributed to Gilbert's syndrome
  • AST < 5 × ULN
  • ALT < 5 × ULN
  • Creatinine ≤ 3 x ULN
  • Subject has no clinical indication of rapidly progressing disease in the opinion of the clinical investigator.
  • Subject is a good candidate for treatment with CAR.κ.28 cell product per the clinical investigator's discretion.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

This study is a single center, open-label phase 1 clinical trial designed to determine the safety of escalating doses of autologous activated T lymphocytes (ATLs) expressing the chimeric antigen receptor specific for the kappa-light chain of human immunoglobulins (CAR.κ) in subjects with relapsed/refractory kappa-positive (κ+) mantle cell and indolent non-Hodgkin lymphomas (NHL). During dose finding, up to 12 subjects will receive a single infusion of ATL product expressing the CAR.κ encoding the CD28 co-stimulatory endodomain (CAR.κ.28). The starting dose will be 5.0 × 105 cells/kg. Up to 3 dose levels of CAR.κ.28 cells will be tested with at least 3 subjects enrolled in each dose cohort before dose escalation is considered based on the incidence of dose limiting toxicity (DLT). Prior to receiving the cell product, subjects will undergo lymphodepletion with fludarabine and bendamustine or cyclophophamide. Dose escalation will be guided by the modified 3+3 design. Any dose level may be expanded to 4-9 subjects to obtain more data at that dose or to include subjects for which insufficient cells are manufactured to enroll on their assigned higher dose level. If due to the expansion the estimated DLT rate at a dose is ≥0.33, the study would not escalate to the next highest dose level and the recommended phase 2 dose (RP2D) would be exceeded. If needed, an expansion cohort will enroll up to 8 subjects at the RP2D to further assess safety and efficacy of CAR.κ.28 cells. Secondary endpoints include evaluation of progression free survival (PFS), response rate (RR), duration of response (DoR) and overall survival (OS). The persistence of CAR.κ.28 cells in the peripheral blood will be assessed as an exploratory objective. The final RP2D including expansion data will be the dose with the DLT rate closest to 0.2. The adoptive transfer of T cells targeting the kappa light chain (CAR.κ) is a promising treatment for patients with relapsed/refractory κ + NHL and has shown encouraging preclinical activity [37]. The CD8α stalk incorporated into CD28 signaling domain within the CAR, may improve the persistence of the CAR.κ T cells. Therefore, subjects in this study are being infused with this newly modified version of CAR.κ.28 so that persistence and efficacy will be improved compared to the older version of the CAR.κ molecule. We hypothesize that CAR.κ.28 will be well tolerated in subjects with relapsed/refractory indolent and aggressive lymphomas positive for the kappa light chain and will show efficacy. We also anticipate that CAR.κ.28 will show fast expansion in the peripheral blood in the first 2 - 3 weeks, but also longer term persistence than the previous version of CAR.κ.28. In this phase 1 single center study, peripheral blood will be collected for production of CAR.κ.28 cells prior to conditioning chemotherapy in subjects with relapsed/refractory κ+ indolent lymphoma including follicular lymphoma grade 1-3b, splenic marginal zone lymphoma, extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone lymphoma, and mantle cell lymphoma. During the approximately 1-2 months necessary for CAR-T cell production, subjects may undergo standard of care treatment ("bridging therapy") per physician's discretion. Subjects must sign consent forms before cells are procured and again prior to undergoing lymphodepleting chemotherapy and cellular treatment. At 2-14 days (preferably 2-4 days) after lymphodepletion with bendamustine and fludarabine, we will infuse the CAR.κ.28 cell product. Subjects in this study will receive CAR.κ.28 cell product in one of the three planned dose escalation cohorts. Dose levels of CAR.κ.28 cells administered will range between 5.0 × 105 cells/kg and 2 × 106 cells/kg. These doses have been evaluated in previous phase 1 studies of CAR-T cell lymphocytes [37-39] including a phase 1 trial targeting the kappa light chain on malignant B cells in which the construct included the CD28 co-stimulatory endodomain [37]. An expansion cohort will enroll up to 8 subjects at the RP2D to further assess safety and efficacy of CAR.κ.28 cells. In all subjects, we will measure the persistence of CAR.κ.28 cells in the peripheral blood at different time points by measuring the level of the transgene and by phenotypic analyses. OUTLINE Cell Procurement Peripheral blood, up to 300 mL (in up to 3 collections) will be obtained from subjects for cell procurement. In subjects with inadequate lymphocyte count in the peripheral blood, a leukapheresis may be performed to isolate sufficient T cells. The parameters for apheresis will be up to 2 blood volumes. Lymphodepleting Regimen Subjects will receive a "pre-conditioning" cytoreductive regimen of bendamustine 70 mg/m2/day administered IV followed by fludarabine 30 mg/m2/day administered IV over 3 consecutive days. These agents will be administered per institutional guidelines. Prophylaxis (e.g., hydration, antiemetics, etc.) needed prior to fludarabine and bendamustine chemotherapy will be provided per institutional guidelines. At the discretion of the clinical investigator, subjects with a known history of intolerance to bendamustine may be considered for lymphodepletion with cyclophosphamide 500 mg/m2/day administered IV followed by an IV dose of fludarabine 30 mg/m2/day administered over 3 consecutive days. These agents will be administered per institutional guidelines. Cell Administration The cellular product consisting of CAR.κ.28 cells will be administered by a licensed healthcare provider (oncology nurse or physician) via intravenous injection over 5 - 10 minutes through either a peripheral or a central line. The volume of infusion will depend upon the concentration of the cells when frozen and the size of the subject. The expected volume will be 1-50cc. Post lymphodepletion, subjects who meet eligibility criteria for cellular therapy will receive CAR.κ.28 cells within 2 - 14 days, but preferably within 2-4 days, after completing the lymphodepleting chemotherapy regimen. During dose finding, a single dose of CAR.κ.28 will be given after lymphodepletion. The cell dose levels that will be evaluated are outlined below. Expansion Cohort, CAR.κ.28 will be given after lymphodepletion. Subjects will receive the RP2D. Duration of Therapy Therapy in LCCC1811-ATL involves a single cell infusion of CAR.K.28 cells. Treatment with at least one infusion will be administered unless:

  • Subject decides to withdraw from study treatment, or
  • General or specific changes in the subject's condition render the subject unacceptable for further treatment in the judgment of the investigator.

Duration of Follow-up Subjects will be followed for up to 15 years for RCR evaluation or until death, whichever occurs first. In addition to this follow-up, subjects removed from study treatment for unacceptable adverse events will be followed until resolution or stabilization of the adverse event. Subjects who experience unequivocal disease progression and start alternate therapy after receiving a cell infusion still be required to complete abbreviated follow up procedures.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would first give blood (up to about 300 mL in up to three collections) for manufacture of the CAR T cells; if needed, a leukapheresis may be performed to collect sufficient T cells. During the roughly 1–2 month manufacturing period you may receive standard “bridging” therapy per your doctor. Before the cell infusion you will receive lymphodepleting chemotherapy (bendamustine plus fludarabine or, if bendamustine is not used, cyclophosphamide plus fludarabine over three days), then get a single intravenous infusion of the CAR.κ.28 cell product (given over about 5–10 minutes through a peripheral or central line). You can expect planned imaging, heart tests (ECG and echocardiogram), blood tests to assess organ function and to measure the infused cells, possible bone‑marrow biopsy for some participants, short‑term safety monitoring, and long‑term follow‑up visits (the record specifies follow‑up for up to 15 years) to track side effects, disease status, and persistence of the engineered cells.

How the study is structured. Open-label, single-group Phase 1 interventional study using a modified 3+3 dose-escalation plan. Participants give blood (up to 300 mL) or may undergo leukapheresis so T cells can be made into the CAR product, receive lymphodepleting chemotherapy (fludarabine with bendamustine or cyclophosphamide), then a single intravenous infusion of CAR.κ.28. Up to 12 subjects enter dose-finding cohorts with the possibility of expanding the recommended phase 2 dose cohort by up to 8 additional subjects; participants are followed for long-term safety including up to 15 years for RCR evaluation.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on splenic marginal zone lymphoma

Clinical trials12 trials listed for splenic marginal zone lymphomaEvery trial the registry lists for splenic marginal zone lymphoma, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in splenic marginal zone lymphoma researchLatest monthly update: July 2026. Includes: Slow disease course. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Nov 12, 2020
Primary completion
Mar 22, 2028 (estimated)
Study completion
Mar 22, 2043 (estimated)
Target enrollment
20 participants (estimated)
Last updated on registry
Jan 20, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
  • National Cancer Institute (NCI)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Lineberger Comprehensive Cancer Center at University of North CarolinaRecruiting

    Chapel Hill, North Carolina, 27599 · United States

    • Catherine Cheng · 919-445-4208 · UNCImmunotherapy@med.unc.edu
    • Kelly Hoye · 919-445-9676 · UNCImmunotherapy@med.unc.edu
    • Natalie Grover, MD
    • Paul Armistead
    • Anne Beaven, MD
    • James Coghill
    • Christopher Dittus, MD
    • Gianpietro Dotti
    • Paul Eldridge
    • Katarzyna Jamieson
    • Emily Kassam
    • Grace Park
    • Alicia Pinto
    • Marcie Riches
    • Barbara Savoldo
    • Jonathan Serody, MD
    • Thomas Shea, MD
    • Benjamin Vincent
    • Kimberly Wehner
    • William Wood
    • Ashley Zanter

Terms used on this page · explanations by MedicalUpdates.ai

Chimeric Antigen Receptor
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
standard of care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
relapsed/refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
histologically confirmed
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
relapsed
A condition that improved with treatment and has since returned or worsened.
allogeneic stem cell transplant
A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
prior lines
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
natural history
A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Karnofsky
A scale from 100 (no complaints) down to 0 that describes how well a person can carry out daily activities. Studies often require a minimum score.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
corticosteroids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
Eligibility Criteria
The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
× ULN
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
ECHO
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
ANC
The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
contraindicated
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
dose finding
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
dose limiting toxicity
A side effect, defined in advance, that is severe enough to limit how far the dose can be raised in a dose-escalation study. How many such events stop escalation is set by the study's rules.
recommended phase 2 dose
The dose chosen at the end of a phase 1 study for testing in later studies, based on safety and other measurements.
endpoints
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
progression free survival
The length of time during and after treatment that a person lives without the condition getting worse, as defined by the study.
overall survival
The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.
Follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
adverse events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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