Second infusion of relma-cel for patients with relapsed B-cell lymphoma
A Single-arm Prospective Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma
This study tests if giving a second dose of relma-cel can help adults with relapsed large B-cell lymphoma who have already had this treatment before.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05806580 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of a second infusion of relma-cel injection in adult patients diagnosed with relapsed or refractory large B-cell lymphoma who have previously received this treatment. Participants will undergo a thorough assessment post-initial treatment to determine the appropriateness of a second infusion based on clinical practice. The study will collect data without grouping, allowing for detailed subgroup analysis based on the collected efficacy and safety data.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory B-cell lymphoma who have previously been treated with relma-cel and have shown some level of disease assessment post-treatment.
Not a fit: Patients who have not received initial treatment with relma-cel or those with significant toxicity from prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed or refractory B-cell lymphoma.
How similar studies have performed: Other studies have shown promising results with CAR-T cell therapies in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- NO.197， Ruijin Er Road — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Weili Zhao, professor
- Email: zwl_trial@163.com
- Phone: +86 021-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.