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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 4

Conditions: Relapsed or Refractory B-cell Lymphoma

Treatments: Drug: Relma-cel

Study type: Interventional

Funder types: Other

Identifiers

NCT05806580

JWCAR029019

Details and patient eligibility

About

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

Full description

This study aims to collect efficacy and safety data from adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) who receive a second infusion of relma-cel injection after initial treatment with relma-cel. The study will not include any form of grouping, and subgroup analysis will be conducted based on the actual data collected.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Relma-cel secondary infusion

Experimental group

Treatment:

Drug: Relma-cel