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Ensayo clínico de infusión de linfocitos T autólogos de sangre periférica expandidos y modificados genéticamente mediante transposones de la familia Sleeping Beauty para expresar un receptor antigénico quimérico con especificidad anti-CD19 conjugado ....l
THE OBJECTIVE OF THE STUDY IS: PHASE 1: - TO EVALUATE THE SAFETY OF TRANSPOCART19 CELL INFUSION IN PATIENTS WITH RELAPSED OR REFRACTORY B-CELL LYMPHOMA. - DETERMINE THE MAXIMUM TOLERATED DOSE (MTD) AND/OR RECOMMENDED DOSE OF TRANSPOCART19 CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY B-CELL LYMPHOMA. PHASE 2: - TO EVALUATE THE EFFICACY OF TRANSPOCART19 CELL INFUSION IN PATIENTS WITH RELAPSED OR REFRACTORY B-CELL LYMPHOMA.
Technical Summary
- PHASE I/IIA MULTICENTER 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.
- Code EudraCT: 2022-001040-23
- Protocol number: TranspoCART19
- Promoter: IBSAL
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
Who can participate?
Clinical trial 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 ....l.
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