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Recruiting Phase 4 NCT05806580

Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma

Trial Parameters

Condition Relapsed or Refractory B-cell Lymphoma
Sponsor Ruijin Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 8
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-05-01
Completion 2027-05-31
Interventions
Relma-cel

Brief Summary

To observe the efficacy and safety of a second infusion of relma-cel injection in patients with relapsed or refractory B-cell lymphoma.

Eligibility Criteria

Inclusion Criteria: * Patients have signed an Informed Consent Form (ICF). * Adults diagnosed with relapsed or refractory B-cell lymphoma who have completed initial treatment with Relma-cel. * Patients must have undergone at least one disease assessment post-initial Relma-cel treatment, and the investigator decides to administer a second treatment (including PR/PD/SD) based on clinical practice. * Before the second infusion, confirm that the prepared dose of relma-cel is sufficient (recommended 80-150 x 10\^6 CAR-T cells), with specific dosage determined by the investigator based on patient condition and dose availability. * Confirm the presence of CD19+ residual tumor tissue, if clinically permissible. * Measure plasma for the absence of anti-drug antibodies (ADA) to relma-cel before the second treatment. * Toxicity related to lymphodepleting chemotherapy (fludarabine and cyclophosphamide), except for hair loss, must have resolved to ≤ Grade 1 or returned to baseline levels before ret

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