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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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To assess the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity [A3B1] conjugated with the co-stimulatory regions 4-1BB and CD3z ) safety on patients with leukemia or lymphoma CD19+ resistant or refractory to treatment and with a prognosis of less than 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult differentiated autologous T-cells | Experimental | Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z. Such cells will be administered in a single infusion intravenously at a total ARI-0001 cell dose of 0.5-10 x 106 / kg body weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adult differentiated autologous T-cells | Biological | After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-CD19 specificity will be transfused. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related mortality (PRM) | Any death not caused directly by leukemia / lymphoma. For the estimation of PRM, relapse or progression of the disease will be considered as a competitive event. | Year 1 |
| Procedure-related mortality (PRM) | Any death not caused directly by leukemia / lymphoma. For the estimation of PRM, relapse or progression of the disease will be considered as a competitive event. | Year 3 |
| Assessment of toxicity | number of adverse events grade III-IV using CTC (common toxicity criteria) | Month 3 |
| Assessment of toxicity | number of adverse events grade III-IV using CTC (common toxicity criteria) | Year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (overall and complete) | Defined differently for each disease:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julio Delgado González, PhD MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic of Barcelona | Barcelona | 08036 | Spain | |||
| Hospital Sant Joan de Deu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40987492 | Derived | Bartolo-Ibars A, Aran A, Johansson AM, Ortiz-Maldonado V, Klein-Gonzalez N, Alonso-Saladrigues A, James E, Urbano-Ispizua A, Rives S, Delgado J, Gonzalez-Navarro EA, Kwok WW, Juan M. T-cell responses against CD19-targeted CAR T cells varnimcabtagene autoleucel (ARI-0001): implications for immune response and therapy outcomes. J Immunother Cancer. 2025 Sep 22;13(9):e010792. doi: 10.1136/jitc-2024-010792. | |
| 40951523 |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Open label
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| Month 3 and Year 1 |
| Progression-free survival | Time lag between infusion of ARI-0001 and the progression of disease or death. Patients alive and in complete remission will be censored at the last follow-up | Year 2 after procedure |
| Overall survival (OS) at 2 years | Time lag between the infusion of ARI-0001 and the death of the patient from any cause. Living patients will be censored at the the last follow-up. | 3 years |
| In vivo survival of ARI-0001 cells in peripheral blood, bone marrow and cerebrospinal fluid | Determined monthly during the first 6 months by flow cytometry and quantitative transgene PCR. | months 1,2,3,4,5,6 |
| In vivo survival of ARI-0001 cells in peripheral blood, bone marrow and cerebrospinal fluid | Determined quarterly from month 6 until the 2 years after infusion, by flow cytometry and quantitative transgene PCR. | months 9,12,15,18,21,24 |
| Quality of life of included patients | Evaluated by a questionnaire completed by patients or their legal guardians | Month 3, 6, 12 |
| Toxicity assessment | defined as number of adverse events of any type occurring throughout the study using the common toxicity criteria | Month 3 and year 1 |
| Barcelona |
| 08950 |
| Spain |
| Derived |
| Martinez-Cibrian N, Ortiz-Maldonado V, Espanol-Rego M, Alserawan L, Navarro S, Albiol N, Lozano M, Charry P, Magnano L, Rivero A, Correa JG, Mozas P, Cortes-Bullich A, Jimenez-Vicente C, Gine E, Montoro-Lorite M, Ramos C, Ayora P, Calderon H, Sanchez-Castanon M, Benitez-Ribas D, Mata-Molanes JJ, Rojas K, Setoain X, Rodriguez S, Murias A, Alcubilla P, Varea S, Olesti E, Bachiller M, Calvo-Orteu M, Sans-Pola C, Saez-Penataro J, de Larrea CF, Lopez-Guillermo A, Gonzalez-Navarro EA, Juan M, Delgado J. Efficacy and safety of the academic anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel for the treatment of relapsed/refractory follicular lymphoma. Hemasphere. 2025 Sep 11;9(9):e70166. doi: 10.1002/hem3.70166. eCollection 2025 Sep. |
| 37905734 | Derived | Martinez-Cibrian N, Ortiz-Maldonado V, Espanol-Rego M, Blazquez A, Cid J, Lozano M, Magnano L, Gine E, Correa JG, Mozas P, Rodriguez-Lobato LG, Rivero A, Montoro-Lorite M, Ayora P, Navarro S, Alserawan L, Gonzalez-Navarro EA, Castella M, Sanchez-Castanon M, Cabezon R, Benitez-Ribas D, Setoain X, Rodriguez S, Brillembourg H, Varea S, Olesti E, Guillen E, Saez-Penataro J, de Larrea CF, Lopez-Guillermo A, Pascal M, Urbano-Ispizua A, Juan M, Delgado J. The academic point-of-care anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel (ARI-0001 cells) shows efficacy and safety in the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma. Br J Haematol. 2024 Feb;204(2):525-533. doi: 10.1111/bjh.19170. Epub 2023 Oct 31. |
| 33010231 | Derived | Ortiz-Maldonado V, Rives S, Castella M, Alonso-Saladrigues A, Benitez-Ribas D, Caballero-Banos M, Baumann T, Cid J, Garcia-Rey E, Llanos C, Torrebadell M, Villamor N, Gine E, Diaz-Beya M, Guardia L, Montoro M, Catala A, Faura A, Gonzalez EA, Espanol-Rego M, Klein-Gonzalez N, Alsina L, Castro P, Jordan I, Fernandez S, Ramos F, Sune G, Perpina U, Canals JM, Lozano M, Trias E, Scalise A, Varea S, Saez-Penataro J, Torres F, Calvo G, Esteve J, Urbano-Ispizua A, Juan M, Delgado J. CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19+ Relapsed/Refractory Malignancies. Mol Ther. 2021 Feb 3;29(2):636-644. doi: 10.1016/j.ymthe.2020.09.027. Epub 2020 Sep 20. |
| 32528460 | Derived | Castella M, Caballero-Banos M, Ortiz-Maldonado V, Gonzalez-Navarro EA, Sune G, Antonana-Vidosola A, Boronat A, Marzal B, Millan L, Martin-Antonio B, Cid J, Lozano M, Garcia E, Tabera J, Trias E, Perpina U, Canals JM, Baumann T, Benitez-Ribas D, Campo E, Yague J, Urbano-Ispizua A, Rives S, Delgado J, Juan M. Point-Of-Care CAR T-Cell Production (ARI-0001) Using a Closed Semi-automatic Bioreactor: Experience From an Academic Phase I Clinical Trial. Front Immunol. 2020 Mar 20;11:482. doi: 10.3389/fimmu.2020.00482. eCollection 2020. |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |