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NOT YET RECRUITING
NCT05982275
PHASE1/PHASE2

Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant

Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2024-12-30

Completion Date

2029-12-31

Last Updated

2024-05-14

Healthy Volunteers

No

Interventions

GENETIC

CARTemis-1

A dose escalation design will be applied in successive patient cohorts until identification of Dose Limiting Toxicity (maximum dose: 6x10\^6 CAR-T/kg divided over 2 days).

Locations (5)

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

Seville, Spain

Hospital Clínico de Valencia

Valencia, Spain