Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology — TranspoCART19

B-cell Lymphoma Recurrent Clinical Trial

Official title:
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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This clinical trial is a Phase I/II, pilot, open-label, national, prospective, multicentre, non-randomised, open-label study to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma whose prognosis is less than 2 years. Phase I: Dose escalation phase with a classic 3+3 design, in which three dose levels of TranspoCART19 will be evaluated: 1 x 106 cells/kg, 3 x106 cells/kg and 5 x 106 cells/kg. The maximum number of patients included in this phase will be 18. Phase II: an expansion cohort with the maximum tolerated dose (MTD) determined in Phase I. Patients will be included in the expansion cohort up to a total of 27, including Phase I patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06378190
Study type	Interventional
Source	Instituto de Investigación Biomédica de Salamanca
Contact	Esperanza López_Franco, PhD
Phone	923 291200
Email	uicec.coordinacion@ibsal.es
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	March 11, 2024
Completion date	October 2028

View Details

See also
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