Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphom
This will be a Phase 1, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with R/R T-ALL or T-LLy. BEAM-201 is an allogeneic anti-CD7 CART therapy.
| Condition(s) | T-Cell Acute Lymphoblastic Leukemia/Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This will be a Phase 1, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with R/R T-ALL or T-LLy. BEAM-201 is an allogeneic anti-CD7 CART therapy. |
| Who can participate | Patients must meet all the following criteria to be eligible for enrollment into the study: 1. Patients (ages ≥ 18 years) or parent/legal guardians (for patients ages \< 18 years) must provide signed, written informed consent according to local IRB and institutional requirements. 2. Ages 0 to 29 years. 3. T-ALL/T-LLy in second or greater relapse, first relapse post-transplant, or chemotherapy-refractory disease. Specifically: 1. Second or greater relapse or post-transplant relapse, defined as: * BM with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease after second documented CR; OR * Flow cytometric confirmation of relapsed T-ALL of at least 0.1% after second CR documented to have been MRD negative \< 0.1%; OR * Any detectable relapsed disease post-allogene |
| Ages | 0 Years to 29 Years |
| Sex | All |
| Lead sponsor | Stephan Grupp MD PhD |
| Locations | Philadelphia, Pennsylvania, United States |
| Start date | 2025-04-29 |
| NCT ID | NCT06934382 |
| Official listing | https://clinicaltrials.gov/study/NCT06934382 |