Trial | NCT04309981  Report issue

Title

Clinical Trial Using Humanized CART Directed Against BCMA (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma to Proteasome Inhibitors, Immunomodulators and Anti-CD38 Antibody.
Pilot Study of the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-BCMA (TNFRSF17) Specificity Humanized Conjugated With the Co-stimulatory Region 4-1BB and Signal-transduction CD3z (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma With Previous Treatment With Proteasome Inhibitor, Immunomodulatory Drug and Anti-CD38 Monoclonal Antibody

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    73
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.
Study Started
May 27
2020
Primary Completion
Apr 01
2025
Anticipated
Study Completion
Apr 01
2025
Anticipated
Last Update
Aug 28
2023

Biological Adult differentiated autologous T-cells with anti-BCMA specificity

After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-BCMA specificity will be transfused.

  • Other names: CARTBCMA

ARI0002h Experimental

Adult differentiated autologous T-cells from peripheral blood, expanded and transducted with a lentivirus to express a chimeric antigen receptor with anti-BCMA (TNFRSF17) specificity conjugated to the 4-1BB co-stimulatory region and signal-transduction CD3z that has been humanized

Criteria 

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
No Results Posted