Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma
A Single-arm Prospective Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma
Ruijin Hospital
8 participants
May 1, 2023
INTERVENTIONAL
Conditions
Summary
To observe the efficacy and safety of a second infusion of relma-cel injection in patients with relapsed or refractory B-cell lymphoma.
Eligibility
Inclusion Criteria8
- 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 Criteria2
- 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
Interventions
Patients who have undergone at least one disease assessment after initial Relma-cel treatment and have not achieved complete remission may receive a second treatment based on clinical practice. The specific dosage will be determined by the investigator according to the patient's condition and available dose reserves.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05806580