drugset / Trial / NCT06101381
CD19-directed CAR-T Cell Therapy for R/R Acute Leukemia and Lymphoma
Phase 1/2
Recruiting
81 enrolled
University of Sao Paulo
Blood Center of Ribeirao Preto · collabHospital das Clínicas de Ribeirão Preto · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this prospective, multicentric, single-arm, phase I/II clinical trial is to evaluate the safety and efficacy of a novel CD19-directed CAR-T cell locally produced in an academic institution in Brazil in patients with refractory or relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Participants will receive a single intravenous infusion of an autologous academic anti-CD19 CAR-T cell and will be followed for 5 years.
Timeline
- Start
- 2024-03-21
- Primary completion
- 2028-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tisagenlecleucel | Cell therapy | — | Intravenous |