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

Last updated: May 13, 2024
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Allogeneic Hematopoietic Stem Cell Transplant

Leukemia

Cancer/tumors

Treatment

CARTemis-1

Clinical Study ID

NCT05982275
CARTemis-1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients > 18 years old with a diagnosis of post-allogeneic transplant relapsemultiple 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 inclusionand 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

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 theexception 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 ventricularejection fraction <40%, carbon monoxide diffusion test <40%, glomerular filtrationrate <50 ml/min, bilirubin >3 normal value (except Gilbert syndrome).

  9. Previous diagnosis of symptomatic amyloid light chain or primary amyloidosis orPOEMS Syndrome.

  10. Pregnant or lactating women.

  11. Women of childbearing age, unable or unwilling to use highly effective contraceptivemethods.

  12. Men who cannot or do not wish to use highly effective contraceptive methods. Thepartner of the male participants, if they are women of childbearing age, must alsouse 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 theexcipients of the product to be infused.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: CARTemis-1
Phase: 1/2
Study Start date:
December 30, 2024
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Site Not Available

  • Complejo asistencial universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • José Antonio Pérez Simón

    Sevilla, 41011
    Spain

    Site Not Available

  • Hospital Clínico de Valencia

    Valencia, 46010
    Spain

    Site Not Available

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