Second infusion of relma-cel for patients with relapsed B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of a second infusion of relma-cel injection in adult patients diagnosed with relapsed or refractory large B-cell lymphoma who have previously received this treatment. Participants will undergo a thorough assessment post-initial treatment to determine the appropriateness of a second infusion based on clinical practice. The study will collect data without grouping, allowing for detailed subgroup analysis based on the collected efficacy and safety data.

Why it matters

Who can join: the full rules

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

Where it's running

• NO.197， Ruijin Er Road
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Weili Zhao, professor
• Email: zwl_trial@163.com
• Phone: +86 021-64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.