NCT06532643 Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects with Relapsed/Refractory Lymphoma
| NCT ID | NCT06532643 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai First Song Biotechnology Co., LTD |
| Condition | Relapsed/Refractory Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2023-08-24 |
| Primary Completion | 2025-09-01 |
Trial Parameters
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Brief Summary
This study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/refractory lymphoma.
Eligibility Criteria
Inclusion Criteria * Patients must meet all of the following criteria to be eligible for the study: 1. Voluntarily participate in the clinical study. The individual or the legal guardian fully understands the study, sign the informed consent form (ICF), and is willing and able to follow and complete all trial procedures. 2. Age ≥ 14 years and \< 70 years. 3. Subjects with refractory or relapsed disease after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation) who are not suitable for other treatment options, such as a second stem cell transplant. The definitions of relapsed/refractory lymphoma include one of the following situations: 1. No response to first-line treatment (primary refractory disease, excluding participants intolerant to first-line treatments). * Disease progression (PD) as assessed after first-line treatment. * Best efficacy of first-line treatment (e.g., 4 cycles of RCHOP) as stable disease (SD), with the duration o