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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
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
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