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Spots Global Cancer Trial Database for Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant

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We do not endorse or review these studies in any way.

Trial Identification

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

Interventions

CARTemis-1

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Jose-Antonio Perez-Simon, MD-PhD

Affiliation: Hospitales Universitarios Virgen del Rocío

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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