Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma
Relapsed or Refractory B-cell Lymphoma
About this trial
This is an interventional treatment trial for Relapsed or Refractory B-cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Informed Consent Form (ICF) was obtained from the patients. Diagnosed relapsed or refractory B-cell lymphomas diffuse large B-cell lymphoma-not otherwise specified diffuse large B-cell lymphoma transformed from follicular lymphoma grade 3b follicular lymphoma primary mediastinal large B-cell lymphoma high-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangements (double/triple hit lymphoma) adult follicular lymphoma refractory to second-line or later systemic therapy or relapsed within 24 months Adult patients who had completed the first treatment with remifentanil injection; The patient had undergone at least one post-treatment disease assessment with Relmacabtagene Autoleucel Injection, and the investigator decided to retreat the patient (including PR\PD\SD) with commercially available Relmacabtagene Autoleucel injection based on clinical practice; Prior to the second infusion, an adequate dose of the manufactured product (80-150x106 CAR-T cells recommended) should be confirmed, at the investigator's discretion based on the patient's condition and dose stockpile; Confirmation of residual tumor tissue CD19+ in patients, if clinically permissible; Absence of antidrug antibody (ADA) to ricciolenz in plasma before retreatment; Toxicity associated with lymphocyte-clearing chemotherapy (fludarabine and cyclophosphamide), with the exception of alopecia, that resolved to ≤ grade 1 or returned to pre-first treatment levels before retreatment. The patients did not have serious adverse reactions during the first treatment, or the adverse reactions during the first treatment had resolved to the baseline level of the first treatment. Exclusion Criteria: Patients with hypersensitivity to the active ingredient or any excipients (dimethyl sulfoxide, compound electrolyte injection, human serum albumin); Patients had uncontrolled systemic fungal, bacterial, viral, or other infections
Sites / Locations
- NO.197, Ruijin Er RoadRecruiting
Arms of the Study
Arm 1
Experimental
single arm
For patients who had undergone at least one disease assessment after the first treatment of Relmacabtagene Autoleucel injection and whose disease status was not complete remission, the investigators decided to give the patients a second treatment of Relmacabtagene Autoleucel injection based on clinical practice, and the specific dosage was determined by the investigators according to the patient's condition and dose reserve