Who may be eligible for the SynKIR-310 for Relapsed/Refractory B-NHL trial?

Inclusion Criteria: * Adult 18 years of age and older. * Histologically confirmed diagnosis of B-NHL before enrollment. * Must have received prior CAR T or were unwilling/unable to receive prior CAR T. * Must have refractory or relapsed disease after receiving 2 prior lines of therapies. * If relapsed/refractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment. * If relapsed/refractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease, and expectation to remain off immunosuppressive therapy through duration of trial * Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Exclusion Criteria: * Previously treated with any investigational agent within 30 days prior to screening. * Any previous or concurrent malignancy, with the following exceptions: Adequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment or adequately treated melanoma skin cancer in-situ; any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level \< 1.0 may also be permitted. * Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis * Known immunodeficiency disease , with the exception of hypoglobulinemia * History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included. * Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry. * Any active uncontrolled systemic fungal, bacterial or viral infection. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

ClinicalTrials.gov record NCT06544265

SynKIR-310 for Relapsed/Refractory B-NHL

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

A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

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 is a Phase 1, first‑in‑human study testing a single intravenous dose of SynKIR-310 in people with relapsed or refractory B‑cell non‑Hodgkin lymphoma. The study will escalate doses in up to four small cohorts to find a recommended Phase 2 dose, then enroll more participants at that dose. Overall, up to 36 participants will be treated; the study focuses on safety, feasibility, and early signs of activity.

What it is studying. The study is testing the safety and feasibility of a single infusion of SynKIR-310 and collecting early data on its activity and how long the modified T cells persist in blood. It also aims to identify a recommended dose for future studies.

What the researchers hope to learn. Scientific goals are to evaluate safety (including adverse events and dose‑limiting toxicities), confirm feasibility of giving SynKIR-310, determine a Recommended Phase 2 Dose, and collect preliminary measures of response, duration of response, and product persistence.

What this study is about

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

This first-in-human (FIH) trial is designed to assess the safety, feasibility and preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to participants with relapsed/refractory B-NHL.

Interventions being studied

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

Biological: SynKIR-310

Eligibility

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

Inclusion criteria

Adult 18 years of age and older.
Histologically confirmed diagnosis of B-NHL before enrollment.
Must have received prior CAR T or were unwilling/unable to receive prior CAR T.
Must have refractory or relapsed disease after receiving 2 prior lines of therapies.
If relapsed/refractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.
If relapsed/refractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease, and expectation to remain off immunosuppressive therapy through duration of trial
Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion criteria

Previously treated with any investigational agent within 30 days prior to screening.
Any previous or concurrent malignancy, with the following exceptions:
Adequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment or adequately treated melanoma skin cancer in-situ; any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level < 1.0 may also be permitted.
Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis
Known immunodeficiency disease , with the exception of hypoglobulinemia
History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.
Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.
Any active uncontrolled systemic fungal, bacterial or viral infection.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study description and what participation involves

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

Detailed description from the registry

This is a Phase 1, FIH, multicenter, open-label study of a single infusion of SynKIR-310 in participants with relapsed/refractory B-NHL. Up to 36 participants, regardless of subtypes of B-NHL, who meet the eligibility criteria, will be treated in the study. Up to 4 cohorts of 3 to 6 participants per cohort will be assessed to determine the safety and feasibility of treatment with SynKIR-310. Doses will be escalated across up to 4 cohorts to determine a Recommended Phase 2 Dose (RP2D). Once the RP2D has been determined, a dose expansion group will enroll additional participants regardless of subtypes of B-NHL at the RP2D to further characterize the safety, feasibility and preliminary efficacy of SynKIR-310 in treating B-NHL.

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.

Participants will have screening tests. If eligible, they receive a single intravenous (IV) infusion of SynKIR-310, a treatment made from their own T cells that have been genetically modified to target CD19. The registry also mentions leukapheresis, a blood-cell collection procedure, but does not describe when or how it is performed in the study. After infusion, blood samples will be taken at multiple times to measure CAR T‑cell persistence and for safety testing, and investigators will assess disease response. Participants will be monitored for adverse events and followed for safety and outcomes for up to 24 months; some screened participants may not ultimately receive the infusion.

How the study is structured. Phase 1, open‑label, single‑group interventional trial. Participants receive one IV infusion of SynKIR-310 (autologous T cells transduced with CD19 KIR‑CAR). Doses will be escalated across up to four cohorts (3–6 participants each) to determine a Recommended Phase 2 Dose (RP2D), after which a dose expansion group will enroll additional participants at the RP2D. Safety, feasibility, response, and persistence of the product will be followed for up to 24 months.

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 Waldenström macroglobulinemia

This trial is also listed on this site under splenic marginal zone lymphoma.

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Nov 1, 2024
Primary completion: September 2028 (estimated)
Study completion: December 2028 (estimated)
Target enrollment: 36 participants (estimated)
Last updated on registry: Apr 14, 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: Verismo Therapeutics

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.

Physician Connect 📞 267-392-6847 ext. 267-392-6847 ✉ physician.connect@verismotherapeutics.com

Participating sites (5)

Colorado Blood Cancer Institute, part of Sarah Cannon Cancer InstituteRecruiting
Denver, Colorado, 80218 · United States
- Cicelia Veloz · 720-754-8068 · cicelia.veloz@sarahcannon.com
- Autumn Wagner · 720-754-8068 · autumn.wagner@scri.com
- Michael T. Tees, MD
Winship Cancer Institute of Emory UniversityRecruiting
Atlanta, Georgia, 30322 · United States
- Molly Stoddart · 404-778-6547 · molly.stoddart@emoryhealthcare.org
- Edmund Waller, MD, PhD
The University of Kansas Cancer CenterRecruiting
Fairway, Kansas, 66205 · United States
- Nurse Navigator · 913-945-7552 · CTNurseNav@kumc.edu
- Joseph McGuirk, DO
Rutgers Cancer InstituteRecruiting
New Brunswick, New Jersey, 08902 · United States
- Hem/Onc Clinical Trial Lab Manager · 732-235-7315 · tn293@cinj.rutgers.edu
- Matthew Matasar, MD
Abramson Cancer Center of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, 19104 · United States
- Brittany Koch · 215-776-5548 · brittany.koch@pennmedicine.upenn.edu
- Stephen Schuster, MD

Terms used on this page · explanations by MedicalUpdates.ai

first-in-human: The first study in which a treatment is given to people. Safety is the main question and the number of participants is usually small.
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.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
CAR T: 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.
relapsed: A condition that improved with treatment and has since returned or worsened.
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.
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.
immunosuppressive: A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
ECOG: A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
investigational agent: 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.
prior to screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
complete remission: No sign of the condition can be found with the tests used in the study. It does not always mean the condition is gone permanently, and the definition depends on the condition and the study.
Exclusion criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
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.
open-label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
eligibility criteria: The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
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.
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.

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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