Clinical Trial Using Humanized CART Directed Against BCMA (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma to Proteasome Inhibitors, Immunomodulators and Anti-CD38 Antibody.
NCT ID: NCT04309981
Last Updated: 2023-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
73 participants
INTERVENTIONAL
2020-05-27
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ARI0002h
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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Fondos ARI (Assistencia Recerca Intensiva)
UNKNOWN
Instituto de Salud Carlos III
OTHER_GOV
Fondo Social La Caixa
UNKNOWN
Sara V. Latorre
OTHER
Responsible Party
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Sara V. Latorre
Clinical Research Manager
Principal Investigators
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Carlos Fernandez de Larrea, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital U. de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Clinic of Barcelona
Barcelona, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Clínico Universitario Virgen de La Arrixaca
Murcia, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen Del Rocío
Seville, , Spain
Countries
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References
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Zugasti I, Tormo-Ratera M, Oliver-Caldes A, Soler-Perromat JC, Gonzalez-Calle V, Moreno DF, Cabanas V, Lopez-Munoz N, Bartolome-Solanas A, Espanol-Rego M, Reguera-Ortega JL, Rosinol L, Lopez-Corral L, Tovar N, Rodriguez-Lobato LG, Alvarez Perez RM, Varea S, Olesti E, Gomez-Grande A, Frutos L, Tamayo P, Juan M, Moraleda JM, Urbano-Ispizua A, Gonzalez-Navarro EA, Martinez-Lopez J, Mateos MV, Tomas X, Setoain X, Fernandez de Larrea C. Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma. Blood Adv. 2025 Feb 11;9(3):571-582. doi: 10.1182/bloodadvances.2024014360.
Oliver-Caldes A, Gonzalez-Calle V, Cabanas V, Espanol-Rego M, Rodriguez-Otero P, Reguera JL, Lopez-Corral L, Martin-Antonio B, Zabaleta A, Inoges S, Varea S, Rosinol L, Lopez-Diaz de Cerio A, Tovar N, Jimenez R, Lopez-Parra M, Rodriguez-Lobato LG, Sanchez-Salinas A, Olesti E, Calvo-Orteu M, Delgado J, Perez-Simon JA, Paiva B, Prosper F, Saez-Penataro J, Juan M, Moraleda JM, Mateos MV, Pascal M, Urbano-Ispizua A, Fernandez de Larrea C. Fractionated initial infusion and booster dose of ARI0002h, a humanised, BCMA-directed CAR T-cell therapy, for patients with relapsed or refractory multiple myeloma (CARTBCMA-HCB-01): a single-arm, multicentre, academic pilot study. Lancet Oncol. 2023 Aug;24(8):913-924. doi: 10.1016/S1470-2045(23)00222-X. Epub 2023 Jul 3.
Oliver-Caldes A, Jimenez R, Espanol-Rego M, Cibeira MT, Ortiz-Maldonado V, Quintana LF, Castillo P, Guijarro F, Tovar N, Montoro M, Benitez-Ribas D, Bataller A, Gonzalez-Navarro EA, Cid J, Lozano M, Perez-Amill L, Martin-Antonio B, Mena MP, Moreno DF, Rodriguez-Lobato LG, Campistol JM, Calvo G, Blade J, Rosinol L, Juan M, Pascal M, Urbano-Ispizua A, Fernandez de Larrea C. First report of CART treatment in AL amyloidosis and relapsed/refractory multiple myeloma. J Immunother Cancer. 2021 Dec;9(12):e003783. doi: 10.1136/jitc-2021-003783.
Other Identifiers
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2019-001472-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CARTBCMA-HCB-01
Identifier Type: -
Identifier Source: org_study_id
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