Clinical Trial Using Humanized CART Directed Against BCMA (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma to Proteasome Inhibitors Immunomodulators and Anti-CD38 Antibody.

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    36
  • sponsor
    Sara V. Latorre
Updated on 26 January 2021

Summary

To assess the safety and efficacy of CARTBCMA ARI0002h in patients with relapsed/refractory multiple myeloma who have received treatment with proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.

Details
Condition Relapsed Refractory Multiple Myeloma
Treatment Adult differentiated autologous T-cells with anti-BCMA specificity
Clinical Study IdentifierNCT04309981
SponsorSara V. Latorre
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients between the age of 18 and 75 years with diagnosis of multiple myeloma
Disease measurable by monoclonal component in serum and/or urine or by free light chains in serum according to the eligibility criteria for clinical trials of the International Myeloma Working Group
Previous two or more lines of treatment. Patients must have received at least a proteasome inhibitor (such as bortezomib or carfilzomib), an immunomodulatory drug (lenalidomide or pomalidomide) and an anti-CD38 monoclonal antibody (such as daratumumab)
Refractory to the last line of treatment
ECOG functional status ranging from 0 to 2
Life expectancy over 3 months
Patients who, after being informed, give their consent by signing the Informed Consent document

Exclusion Criteria

Previous allogeneic transplant in the prior 6 months to inclusion or GVHD that requires active systemic immunosuppressive treatment
Absolute lymphocyte count <0.1x10^9/ L
Previous neoplasia, except if patients have been in complete remission > 3 years, except for cutaneous carcinoma (non-melanoma)
Active infection that requires treatment
Active infection by HIV, HBV or HCV
Uncontrolled medical disease
Severe organic condition that meets any of the following criteria: EF <40%, DLCO <40%, EGFR <50 ml / min, bilirubin> 3 times normal value (except Gilbert syndrome)
Previous diagnosis of symptomatic AL amyloidosis
Pregnant or lactating women. Women of childbearing age should have a negative pregnancy test in the screening phase
Women of childbearing age, including those whose last menstrual cycle was in the year prior to screening, who cannot or do not wish to use highly effective contraceptive methods from the beginning until the end of the study
Men who cannot or do not wish to use highly effective contraceptive methods from the beginning to the end of the study
Contraindication to receive conditioning chemotherapy
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