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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

Treatment groups

25 Participants
are divided into 1 treatment group