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Clinical Trials in China / NCT05806580
Recruiting Phase 4

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

NCT05806580 · tracked via the Priya Life Science China tracker
Sponsor
Ruijin Hospital
Phase
Phase 4
Started
2023-05-01
Last updated
2024-10-23

Condition(s) studied

Relapsed or Refractory B-cell Lymphoma

Investigational drug(s) / intervention(s)

Relma-cel

Relma-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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
NO.197, Ruijin Er Road Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05806580 on ClinicalTrials.gov ↗ ← All trials in China