NCT05806580 Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma
| NCT ID | NCT05806580 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ruijin Hospital |
| Condition | Relapsed or Refractory B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 8 participants in total. It began in 2023-05-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05806580 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed or Refractory B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05806580 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05806580 currently recruiting?
Yes, NCT05806580 is actively recruiting participants. Contact the research team at zwl_trial@163.com for enrollment information.
Where is the NCT05806580 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05806580 clinical trial?
NCT05806580 is sponsored by Ruijin Hospital. The trial plans to enroll 8 participants.