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
2 other identifiers
interventional
73
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2020
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedStudy Start
First participant enrolled
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedAugust 28, 2023
July 1, 2023
4.8 years
March 9, 2020
August 25, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Overall response rate (ORR)
3 months
Cytokine release syndrome rate
within 30 days of first infusion
Secondary Outcomes (17)
Duration of the response
up to 36 months after treatment
Response rate
over the first year
Complete response rate (CR)
at month 3 and month 6 of first infusion
Overall response rate (ORR)
at month 6 of first infusion
Time to complete response
up to 36 months after treatment
- +12 more secondary outcomes
Study Arms (1)
ARI0002h
EXPERIMENTALAdult 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
Interventions
After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-BCMA specificity will be transfused.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sara V. Latorrelead
- Fondos ARI (Assistencia Recerca Intensiva)collaborator
- Instituto de Salud Carlos IIIcollaborator
- Fondo Social La Caixacollaborator
Study Sites (7)
Hospital U. de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Clinic of Barcelona
Barcelona, 08036, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Clínico Universitario Virgen de La Arrixaca
Murcia, 30120, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Del Rocío
Seville, 41013, Spain
Related Publications (3)
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.
PMID: 39602341DERIVEDOliver-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.
PMID: 37414060DERIVEDOliver-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.
PMID: 34876408DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Fernandez de Larrea, MD,PhD
Hospital Clinic of Barcelona
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Research Manager
Study Record Dates
First Submitted
March 9, 2020
First Posted
March 17, 2020
Study Start
May 27, 2020
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
August 28, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share