About this trial
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.
Eligibility criteria
Qualifiers
Patients > 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma.
Measurable disease at the time of screening
Previous treatment with ≥2 lines before and/or after allogeneic transplant.
Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active graft-versus-host disease.
Disqualifiers
Active systemic immunosuppressive treatment
Patients who have previously received treatment with CAR-T Anti-BCMA.
Absolute lymphocyte count <0.2x109/L
Previous neoplasm, except if it has been in complete remission >3 years, with the exception of skin carcinoma (non-melanoma)
Trial design
Treatments tested in this trial
- CARTemis-1