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

Sara V. Latorre

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Relapsed/Refractory Multiple Myeloma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04309981

2019-001472-11 (EudraCT Number)

CARTBCMA-HCB-01

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

ARI0002h

Experimental group

Description:

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

Treatment:

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