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.
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.
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)
Sequential
CARTemis-1
GeneticA 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).
Purity of CARTemis-1
Number of cases in which, after performing apheresis, the manufacturing process is completed and CARTemis-1 cells are infused
Maximum tolerated dose
To determine the maximum tolerated dose of CarTemis-1
Infusion reactions
To appearance of any of the following symptoms after intravenous administration of CARTemis-1: cardiac events, chills, dyspnea, fatigue, sudden hypertension, hypotension, nausea, pain, fever, skin rash, and urticaria.
Tumor lysis syndrome
To increase nucleic acids, potassium, and phosphate in the blood
Number of Participants with cytopenias
Neutropenias or thrombopenias
Number of Participants with prolonged cytopenias
Neutropenias or thrombopenias (grade ≥3) for more than 6 weeks
Duration of clinical response
Duration of clinical response as assessed by Urinalysis (immunofixation, proteinuria and 24-h urine proteinogram), Blood tests (total immunoglobulin A, G and M, immunofixation and proteinogram (M component) in serum; serum free light chains), Bone Marrow Aspirate and Positron Emission Tomography.
Overall response rate
Overall response rate as assessed by criteria of the International Myeloma Working Group
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