Universal CAR-T therapy for CD19-positive B‑cell non-Hodgkin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single‑center, single‑arm, open‑label study enrolling 3–6 adult subjects with measurable CD19‑positive B‑cell non‑Hodgkin lymphoma. Participants receive a fixed dose of BRL‑301 (5×10^6 cells/kg) and are followed for safety, tolerability, and signs of clinical response. Key eligibility includes ECOG 0–1, adequate organ function, LVEF ≥55%, and no prior anti‑CD19 or CAR‑T therapies. The study aims primarily to characterize early safety and any preliminary efficacy signals of this universal CAR‑T approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing to participate in this clinical study and sign an informed consent form;
2. Age ≥ 18 years old;
3. Estimated survival time ≥ 3 months;
4. At least one measurable lesion;
5. CD19 positively expressed;
6. ECOG score 0-1；
7. Hematology, coagulation and biochemistry parameters meeting the requirements;
8. LVEF ≥ 55%;
9. No severe pulmonary disorders;

Exclusion Criteria:

1. Pregnant or lactating women;
2. Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant;
3. Subjects who previously received anti-CD19 targeted therapy;
4. Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;
5. History of Richter's transformation of chronic lymphocytic leukemia (CLL);
6. Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy;
7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
8. Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune disorders);
9. Active autoimmune disorders requiring immunotherapy, including but not limited to end organ damages caused by autoimmune disorders (e.g., Crohn's disease, rheumatoid arthritis, and systemic lupus erythematosus) in the past 2 years, or requiring systemic application of immunosuppressive drugs or other drugs for systemic control of diseases;
10. Primary immunodeficiency;
11. History of other malignancies;
12. Patients with severe cardiovascular disorders;
13. Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.

Where it's running

• Shanghi Tongji Hospital (Tongji Hospital of Tongji University)
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Ping Li, phD
• Phone: 13564181131

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

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• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

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• Loncastuximab tesirine plus rituximab as bridging therapy before CAR-T for relapsed or refractory large B‑cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.