ClinicalTrials.gov record NCT04429438

Multi-CAR-T Cells Targeting B Cell Lymphomas

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 5, 2026

Primary, Booster and Consolidation Multi-CAR-T Cell Therapy for the Treatment of Refractory B Cell Lymphomas

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
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 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age6 months old to 75 years old
SexAll
LocationChina
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 I/II interventional trial tests a combination of fourth‑generation CAR‑T cell infusions given as primary, booster, and consolidation therapy for people with relapsed or refractory B cell lymphoma, including primary mediastinal B‑cell lymphoma (PMBCL) and lymphoma involving the central nervous system (CNS‑BCL). Patients are selected after confirmation of target antigens on their tumor tissue. The study will measure safety and tumor response and will investigate a simplified, standardized lentiviral vector and cell production protocol.

What it is studying. The study is testing a multi‑CAR‑T treatment strategy that uses fourth‑generation CAR‑T cells targeting CD19 and one or more alternative B‑cell surface molecules (CD20, CD22, CD70, PSMA, CD13, CD79b, GD2). It aims to evaluate safety and long‑term anti‑tumor activity of giving these CAR‑T products as initial, booster, and consolidation infusions, and to develop a simplified and standardized lentiviral vector and cell production process. Target antigen expression on tumor specimens will be confirmed before enrollment.

What the researchers hope to learn. Scientific goals are to assess the safety of multiple fourth‑generation CAR‑T cell infusions, measure objective tumor responses, evaluate longer‑term efficacy in highly resistant B cell lymphomas (including PMBCL and CNS‑BCL), and develop a simplified, standardized lentiviral vector and cell manufacturing protocol.

What this study is about

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

This study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting B cell surface molecules including CD19 and alternative CARTs as booster and consolidation treatment for patients with highly resistant B cell lymphomas, including primary mediastinal B cell lymphoma (PMBCL) and BCL involving central nervous system (CNS-BCL). Clinical response and development of a simplified and standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Interventions being studied

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

Biological
  • 4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2

Eligibility

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

Inclusion criteria

  • Age older than 6 months.
  • Primary B cell lymphoma surface expression of CD19 and/or CD22/CD70/PSMA/ CD13/CD79b/GD2 molecules.
  • The KPS score over 80 points, and survival time is more than 1 month.
  • Greater than Hgb 80 g/L.
  • No contraindications to blood cell collection.

Exclusion criteria

  • Accompanied with other active diseases, and difficult to assess response after treatment.
  • Bacterial, fungal, or viral infection, unable to control.
  • Living with HIV.
  • Active HBV and HCV infection.
  • Pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment.
  • Prior failed CAR-T treatment.

Study description and what participation involves

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

Detailed description from the registry

Important Regulatory Notice: This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China. ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities. Chimeric antigen receptor (CAR) T cell therapy has proven effective in treating B cell malignancies. However, post CD19-CART relapses occur at high rate due to the CD19 antigen loss or the exhaustion of CART cells. Furthermore, the success of treating relapsed/refractory B cell lymphoma (BCL) such as primary mediastinal B-cell lymphoma (PMBCL) and CNS-involved BCL has been limited. To overcome tumor escape and prolong in vivo CART efficacy, we have developed a novel multiple CAR-T therapy regimen including booster and consolidation CART applications to to target highly-refractory cancer. Selected patients will be enrolled after target antigen confirmation including CD19, CD20, CD22, CD70, CD13, CD79b, GD2 and PSMA through immunostaining of their tumor specimens. The aim is to evaluate safety and long term efficacy of the multiple CART therapy strategy in the BCL patients.

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.

Tumor specimens will be tested by immunostaining to confirm target antigens (examples listed in the record include CD19, CD20, CD22, CD70, PSMA, CD13, CD79b, and GD2). If enrolled, participants will undergo collection of blood cells for manufacture of multiple 4SCAR gene‑engineered T cells and will receive infusions of those CAR‑T cells. Researchers will monitor safety using the CTCAE v4 adverse-event scale for about 24 weeks and will assess anti-tumor response using RECIST v1.1 up to 1 year. The registry record does not give a detailed visit schedule or list other specific tests or procedures.

How the study is structured. This is an interventional, single‑group (non-randomized), open‑label Phase I/II study. Eligible participants will receive a combination of fourth‑generation CAR‑T cell products (4SCAR19 plus one or more alternative CAR‑T products listed in the record). Safety will be monitored and graded using CTCAE criteria through 24 weeks; anti‑tumor responses will be assessed using RECIST v1.1 up to one year. The study also includes tumor immunostaining to confirm target antigens and investigation of the lentiviral vector and cell production workflow.

Questions you could ask

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

  • The registry lists this study under B Cell Lymphoma (BCL). Does it apply to my diagnosis?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. 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 Gaucher disease

Clinical trials64 trials listed for Gaucher diseaseEvery trial the registry lists for Gaucher disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Gaucher disease researchLatest monthly update: September 2026. Includes: Platelet release. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 1, 2027 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Study completion
Dec 31, 2030 (estimated)
Target enrollment
11 participants (estimated)
Last updated on registry
Aug 26, 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
Shenzhen Geno-Immune Medical Institute

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)

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.
KPS
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.
contraindications
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.
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.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
sponsor
The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
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.

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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