RecruitingPhase 4NCT05806580

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


Sponsor

Ruijin Hospital

Enrollment

8 participants

Start Date

May 1, 2023

Study Type

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

Min Age: 18 Years

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

DRUGRelma-cel

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)

NO.197, Ruijin Er Road

Shanghai, Shanghai Municipality, China

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NCT05806580