Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/NHL
Plain-language summary
This Phase 1, Phase 2 trial is testing CD5-targeted CAR-T cells for people whose T-cell lymphoma has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. This trial does not currently list US sites.
Who can join (key eligibility)
- Age 3 Years to 70 Years years
- Lymphoma came back or did not respond to prior treatment
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
CD5-targeted CAR-T cells (BIOLOGICAL): Phase I: Eligible patients will receive a single infusion of CD5-targeted CAR-T cells at one of three dose levels (0.5 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, or 2.0 × 10⁶ cells/kg) following fludarabine and cyclophosphamide (FC) lymphodepleting chemotherapy. A 3+3 dose-escalation design will be used to determine the recommended Phase II dose (RP2D) based on safety, dose-limiting toxicities (DLTs), and preliminary efficacy. Phase II: Patients will receive CD5-targeted CAR-T cells at the RP2D following FC lymphodepleting chemotherapy.
- Drugs / treatments
- CD5-targeted CAR-T cells
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details