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

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

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 retreatment.
* Patients must not have experienced severe adverse reactions during the first treatment, or any adverse reactions must have resolved to baseline levels from the first treatment.

Exclusion Criteria:

* Patients with hypersensitivity to active ingredients or any excipients (e.g., dimethyl sulfoxide, compound electrolyte injection, human albumin).
* Patients with uncontrolled systemic fungal, bacterial, viral, or other infections

Conditions2

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