CAR T cell therapy for relapsed large B-cell 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 open-label, single-arm study aims to evaluate the efficacy, safety, and pharmacokinetics of relmacabtagene autoleucel (relma-cel) in adult patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) in China. Participants must have histologically confirmed R/R LBCL and have previously undergone at least two lines of therapy, including autologous hematopoietic stem cell transplantation. The study will administer a recommended dose of 1×10^8 CAR+T cells to assess treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ≥18 years old;
2. Sign on the informed consent;
3. Subjects must have histologically confirmed Large B-cell Lymphoma;
4. Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT);
5. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
7. Adequate organ function;
8. Adequate vascular access for leukapheresis procedure;
9. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
10. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
11. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.

Exclusion Criteria:

1. Primary CNS lymphoma;
2. History of another primary malignancy that has not been in remission for at least 2 years;
3. Subjects has HBV,HCV,HIV or syphilis infection at the time of screening;
4. Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
5. Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
6. Presence of acute or chronic graft-versus-host disease(GVHD);
7. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
8. Pregnant or nursing woman;
9. Subjects using of any chemotherapy,corticosteroid,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
10. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
11. Received CAR T-cell or other genetically-modified T-cell therapy previously.

Where it's running

• Tianjin Cancer Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Huilai Zhang — Tianjin Cancer Hospital Airport Hospital
• Study coordinator: Relma-cel Medical
• Email: JWCAR029Medical@jwtherapeutics.com
• Phone: +86 21 50464201

Similar studies

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

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• Using BHB with CAR-T therapy for lymphoma treatment

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• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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• Radiation, Vancomycin, and CAR-T for B-Cell Lymphoma

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• Voice monitoring for side effects during CAR T-cell therapy

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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.