NCT05982275
Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant
Not Yet Recruiting · Phase 1, Phase 2 · Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · registry updated 2024-05-14
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
- Eastern Cooperative Oncology Group functional status from 0 to 1.
- Life expectancy greater than 3 months (at the time of screening)
Exclusion
- 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)
- Active infection requiring treatment.
- Active HIV, hepatitis B virus or hepatitis C virus infection.