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

Recruiting now · Phase 4

Conditions studied: Relapsed or Refractory B-cell Lymphoma

In brief

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

Key facts

Study ID

NCT05806580

Run by

Ruijin Hospital

People needed

8

Starts

2023-05-01

Expected to finish

2027-12-31

Last updated by the study team

2024-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• NO.197， Ruijin Er Road — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.