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Brief Title: Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant
Official Title: Anti-BCMA Chimeric Antigen Receptor (CARTemis-1) T-lymphocyte Therapy in the Treatment of Patients With Multiple Myeloma in Relapse After Allogeneic Transplant: Endothelial Growth Factor Receptor Expression as a Control Mechanism of Treatment-derived Complications
Study ID: NCT05982275
Brief Summary: Most patients with multiple myeloma (MM) die due to relapse resistant to current treatment, including treatment with anti-B cell maturation antigen (BCMA) CAR-T cells. To overcome some of the potential limitations of this therapy, a new and optimized Anti-BCMA CAR-T has been developed, with the aim of using it in patients with MM who relapse after Allogeneic Haematopoietic Haematopoietic Progenitor. This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity is identified, Phase II will begin to assess the efficacy of the procedure.
Detailed Description: This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity is identified (up to a maximum dose of 6x106 CAR-T/kg divided over 2 days), phase II of the trial will begin to assess the efficacy of the procedure. A number of 25 patients will be included to evaluate.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain
Hospital Santa Creu i Sant Pau, Barcelona, , Spain
Complejo asistencial universitario de Salamanca, Salamanca, , Spain
José Antonio Pérez Simón, Sevilla, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
Name: Jose-Antonio Perez-Simon, MD-PhD
Affiliation: Hospitales Universitarios Virgen del Rocío
Role: PRINCIPAL_INVESTIGATOR