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

NCT ID: NCT05982275

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2029-12-31

Brief 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.

Conditions

Multiple Myeloma; Allogeneic Stem Cell Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CARTemis-1

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

Group Type: EXPERIMENTAL

CARTemis-1

Intervention Type: GENETIC

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).

Interventions

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).

Intervention Type: GENETIC

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose-Antonio Perez-Simon, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Hospitales Universitarios Virgen del Rocío

Locations

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Santa Creu i Sant Pau

Barcelona, , Spain

Complejo asistencial universitario de Salamanca

Salamanca, , Spain

José Antonio Pérez Simón

Seville, , Spain

Hospital Clínico de Valencia

Valencia, , Spain

Countries

Spain

Central Contacts

Jose-Antonio Perez-Simon, MD-PhD

Role: CONTACT

josea.perez.simon.sspa@juntadeandalucia.es

0034955013414

Clara Rosso, MD-PhD

Role: CONTACT

claram.rosso.sspa@juntadeandalucia.es

0034955013414

Facility Contacts

Aranzazu Bermúdez-Rodríguez, M.D. Ph.D.

Role: primary

Javier Briones, MD-PhD

Role: primary

Mª Victoria Mateos, MD-Phd

Role: primary

José Antonio Pérez Simón, MD-PhD

Role: primary

josea.perez.simon.sspa@juntadeandalucia.es

0034955013260

Carlos Solano Vercet, M.D. Ph.D.

Role: primary

Other Identifiers

CARTemis-1

Identifier Type: -

Identifier Source: org_study_id