Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology

Phase 1/2 Recruiting 27 enrolled Instituto de Investigación Biomédica de Salamanca Fundación Canaria Instituto de Investigación Sanitaria de Canarias · collab Fundación para la Investigación Biomédica del Hospital 12 de Octubre · collab Spanish Clinical Research Network - SCReN · collab

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2024-03-11
Primary completion: 2029-07
Completion: 2030-07

Publications

Diez B, Calvino C, Fernandez-Garcia M, Rodriguez-Marquez P, Rodriguez-Diaz S, Martinez-Turillas R, Ceballos C, Illarramendi J, Serrano-Lopez J, Miskey C, Navarro-Bailon A, Lopez-Corral L, Llamas P, Redondo M, Sanchez-Guijo F, Rifon J, Alfonso-Pierola A, Ivics Z, Inoges S, Lopez-Diaz de Cerio A, Yanez R, Bueren JA, Rodriguez-Madoz JR, Prosper F. Generation and GMP scale-up of human CAR-T cells using non-viral Sleeping Beauty transposons for B cell malignances. Mol Ther Methods Clin Dev. 2025 Jan 31;33(1):101425. doi: 10.1016/j.omtm.2025.101425. eCollection 2025 Mar 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TranspoCART19	Cell therapy	1 cells/kg	—
Subject	TranspoCART19	Cell therapy	3 cells/kg	—
Subject	TranspoCART19	Cell therapy	5 cells/kg	—

Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology

Summary

Timeline

Publications

Drugs

Indications