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

Launched by CHANGHAI HOSPITAL · Apr 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Relmacabtagene Autoleucel injection for adults with certain types of B-cell lymphoma that have either come back after treatment or did not respond to previous therapies. The goal is to see how effective and safe this second infusion of the treatment is for patients who have already had a first round of therapy. To participate, patients need to have specific types of relapsed or refractory B-cell lymphoma and must have completed their initial treatment with the first infusion of this therapy.

Eligible participants will be adults who have given their consent to join the study and have had at least one assessment showing their disease status after the first treatment. They should also have a certain level of CAR-T cells available for the second treatment, and their previous side effects from the first treatment should have improved. Throughout the trial, participants can expect careful monitoring and support from the medical team to ensure their safety and well-being as they receive this new treatment. The trial is not yet recruiting participants, but it aims to provide more options for those struggling with these challenging types of lymphoma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed Consent Form (ICF) was obtained from the patients.
• • Diagnosed relapsed or refractory B-cell lymphomas
• • 1. diffuse large B-cell lymphoma-not otherwise specified
• • 2. diffuse large B-cell lymphoma transformed from follicular lymphoma
• • 3. grade 3b follicular lymphoma
• • 4. primary mediastinal large B-cell lymphoma
• • 5. high-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangements (double/triple hit lymphoma)
• • 6. 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