A Single-arm Prospective Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma

• Status: Recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of post-marketing Regiorense injection secondary infusion in the treatment of adult patients with relapsed or refractory B-cell lymphoma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital

Criteria

Inclusion Criteria:

1. nformed Consent Form (ICF) was obtained from the patients.

2. Established relapsed or refractory B-cell lymphomas (including 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); And 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;

3. The patient had undergone at least one post-treatment disease assessment with remifolencil injection, and the investigator decided to retreat the patient (including PR\ PD\ SD) with commercially available remifolencil injection based on clinical practice;

4. 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.

5. Confirmation of residual tumor tissue CD19+ in patients, if clinically permissible.

6Absence of antidrug antibody (ADA) to ricciolenz in plasma before retreatment. 7.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.

8.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:

1. Patients with hypersensitivity to the active ingredient or any excipients (dimethyl sulfoxide, compound electrolyte injection, human serum albumin);

2. Patients had uncontrolled systemic fungal, bacterial, viral, or other infections