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

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

NCT ID: NCT05982275

Condition: Multiple Myeloma
Allogeneic Stem Cell Transplantation

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Conditions: Keywords:
Chimeric antigen receptor-T cell therapy
B-Cell Maturation Antigen

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Genetic
Intervention name: CARTemis-1
Description: 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).
Arm group label: CARTemis-1

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
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. The partner of the male participants, if they are women of childbearing age, must also use highly effective contraceptive methods during the study period. 13. Contraindication to receive lymphodepleting chemotherapy. 14. Patients with known hypersensitivity to the active ingredients or any of the excipients of the product to be infused.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hospital Universitario Marques de Valdecilla

Address:
City: Santander
Zip: 39008
Country: Spain

Contact:
Last name: Aranzazu Bermúdez-Rodríguez, M.D. Ph.D.

Facility:
Name: Hospital Santa Creu i Sant Pau

Address:
City: Barcelona
Zip: 08025
Country: Spain

Contact:
Last name: Javier Briones, MD-PhD

Facility:
Name: Complejo asistencial universitario de Salamanca

Address:
City: Salamanca
Zip: 37007
Country: Spain

Contact:
Last name: Mª Victoria Mateos, MD-Phd

Facility:
Name: José Antonio Pérez Simón

Address:
City: Sevilla
Zip: 41011
Country: Spain

Contact:
Last name: José Antonio Pérez Simón, MD-PhD

Phone: 0034955013260
Email: josea.perez.simon.sspa@juntadeandalucia.es

Facility:
Name: Hospital Clínico de Valencia

Address:
City: Valencia
Zip: 46010
Country: Spain

Contact:
Last name: Carlos Solano Vercet, M.D. Ph.D.

Start date: December 30, 2024

Completion date: December 31, 2029

Lead sponsor:
Agency: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Agency class: Other

Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05982275