CAR T cell therapy for relapsed large B-cell lymphoma
An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed or Refractory (R/R) LBCL
This study is testing a new CAR T cell therapy to see if it can help adults with relapsed large B-cell lymphoma who haven't responded to previous treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Ming Ju Biotechnology Co., Ltd. Industry-sponsored |
| Drugs / interventions | rituximab, CAR T, chemotherapy, radiation |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06479356 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed relapsed or refractory large B-cell lymphoma who have undergone prior treatments.
Not a fit: Patients who have not received prior CD19-targeted therapy or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat relapsed or refractory large B-cell lymphoma.
How similar studies have performed: Other studies using CAR T cell therapy for similar conditions have shown promising results, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tianjin, Tianjin Municipality
- Tianjin Cancer Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Huilai Zhang — Tianjin Cancer Hospital
- Study coordinator: Relma-cel Medical
- Email: JWCAR029Medical@jwtherapeutics.com
- Phone: +86 21 50464201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.