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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001472-11 | EudraCT Number |
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| Name | Class |
|---|---|
| Fondos ARI (Assistencia Recerca Intensiva) | UNKNOWN |
| Instituto de Salud Carlos III | OTHER_GOV |
| Fondo Social La Caixa | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adult differentiated autologous T-cells with anti-BCMA specificity | Biological | After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-BCMA specificity will be transfused. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | 3 months | |
| Cytokine release syndrome rate | within 30 days of first infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the response | up to 36 months after treatment | |
| Response rate | over the first year | |
| Complete response rate (CR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Fernandez de Larrea, MD,PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital U. de Santiago de Compostela | Santiago de Compostela | A Coruña | 15706 | Spain | ||
| Clinica Universidad de Navarra |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39602341 | Derived | 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. | |
| 37414060 |
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|
| 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 |
| Response rate of extramedullary disease by PET-CT | up to 36 months after treatment |
| Negative MRD rate in bone marrow | at month 3 and month 6 of first infusion |
| Response rate of extramedullary disease by PET-TC | at month 3 |
| Progression free survival (PFS) | at month 12, and up to 36 months after treatment |
| Overall survival (OS) defined as the time elapsed between the infusion of ARI0002h and the death of the patient from any cause | up to 36 months after treatment |
| Presence of tumor lysis syndrome | up to 36 months after treatment |
| Presence of cytokine release syndrome | up to 36 months after treatment |
| Presence of neurological toxicity | up to 36 months after treatment |
| Presence of prolonged cytopenia | up to 36 months after treatment |
| Persistence of CART BCMA ARI0002 in peripheral blood | month 1, 2, 3, 4, 5, 6 and every 6 months until 2 years of follow up |
| Expression of BCMA | at screening, at day +28, at day +100, at month 6, 12, 18 and 24 |
| Levels of soluble BCMA in serum | at screening, at day 0, +3, +7,+14,+28, +70 +100, at month 4, 5, 6, 7, 8, 9, 1,11, 12, 18 and 24 |
| 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 |
| Derived |
| 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. |
| 34876408 | Derived | 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. |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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