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

Study acronym: CARTemis-1
StatusNot Yet Recruiting
PhasePhase 1/2
Started2024-12-30
View on ClinicalTrials.gov ↗

Amendment history

2024-05-13
Study Identification, Study Status, Eligibility v3
Eligibility criteria+273 characters
[...] do not wish to use highly effective contraceptive methods. The partner of the male participants, if they are women of childbearing age, must also use highly effective contraceptive methods during the study period. Contraindication to receive lymphodepleting chemotherapy. Patients with known hypersensitivity to the active ingredients or any of the excipients of the product to be infused.
2024-03-18
Study Status v2
Primary completion date2028-01-31→2029-12-31
Completion date2028-01-31→2029-12-31
Start date2024-01-30→2024-12-30
2023-10-18
Study Identification, Study Status v1
Start date2023-09-30→2024-01-30
Study title-2 characters
Trial of an Investigational Drug After Rejecting the RejectionRelapse of an Allogeneic Transplant
2023-08-01
Original filing
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.
Trial Details
NCT Number NCT05982275
Lead Sponsor Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions Multiple Myeloma, Allogeneic Stem Cell Transplantation
Enrollment 25 participants
Start Date 2024-12-30
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-05-14