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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients > 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma. 2. Measurable disease at the time of screening. 3. Previous treatment with ≥2 lines before and/or after allogeneic transplant. 4. Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active graft-versus-host disease. 5. Eastern Cooperative Oncology Group functional status from 0 to 1. 6. Life expectancy greater than 3 months (at the time of screening) 7. Patients who give their consent by signing the Informed Consent document.

Exclusion Criteria:

1. Active systemic immunosuppressive treatment. 2. Patients who have previously received treatment with CAR-T Anti-BCMA. 3. Absolute lymphocyte count <0.2x109/L. 4. Previous neoplasm, except if it has been in complete remission >3 years, with the exception of skin carcinoma (non-melanoma) 5. Active infection requiring treatment. 6. Active HIV, hepatitis B virus or hepatitis C virus infection. 7. Uncontrolled medical illness. 8. Severe organic disease that meets any of the following criteria: left ventricular ejection fraction <40%, carbon monoxide diffusion test <40%, glomerular filtration rate <50 ml/min, bilirubin >3 normal value (except Gilbert syndrome). 9. Previous diagnosis of symptomatic amyloid light chain or primary amyloidosis or POEMS Syndrome. 10. Pregnant or lactating women. 11. Women of childbearing age, unable or unwilling to use highly effective contraceptive methods. 12. Men who cannot or do not wish to use highly effective contraceptive methods. 13. Contraindication to receive lymphodepleting chemotherapy.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05982275
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jose-Antonio Perez-Simon, MD-PhD
Principal Investigator Affiliation	Hospitales Universitarios Virgen del Rocío
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma, Allogeneic Stem Cell Transplantation

Additional Details

This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity is identified (up to a maximum dose of 6x106 CAR-T/kg divided over 2 days), phase II of the trial will begin to assess the efficacy of the procedure. A number of 25 patients will be included to evaluate.

Arms & Interventions

Arms

Experimental: CARTemis-1

Dose escalation sequential cohorts CARTemis-1 will be self-administered intravenously one or two days, depending on the dose administered.

Interventions

Genetic: - CARTemis-1

A 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).

Contact a Trial Team

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