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Multicentre Phase I/IIa Study of Infusion of Autologous Peripheral Blood T Lymphocytes Expanded and Genetically Modified Using Sleeping Beauty Family Transposons to Express a Chimeric Antigenic Receptor With Anti-CD19 Specificity Conjugated to the 4-1BB Co-stimulatory Region and CD3z and huEGFRt Signal Transmission (TranspoCART19) in Patients With Relapsed or Refractory B-cell Lymphoma
The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are: Maximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months.
Details
| Lead sponsor | Instituto de Investigación Biomédica de Salamanca |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 27 |
| Start date | 2024-03-11 |
| Completion | 2030-07 |
Conditions
- Refractory B-Cell Lymphoma
- B-cell Lymphoma Recurrent
Interventions
- CAR-T cells therapy
Primary outcomes
- Maximum tolerated dose (MTD) — 1 month
Determine the maximum tolerated dose (MTD) and/or recommended dose of TranspoCART19 cells in patients with relapsed or refractory B-cell lymphoma. - Efficiency — 3 month
Determine best response rate achieved (overall and complete).
Countries
Spain