Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-5072-13-97-00 | Other Identifier | EU CT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
ths study consist in testing a CAR T therapy (ARI0003 cells (antiCD19 and antiBCMA) in patients suffering relapsed NHL (that means that symptoms of NHL reappeared ) or refractory (that means that they did not respond to other treatments). This is a first in human study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARI0003 | Experimental | ARI0003 will be administered intravenously under a split regime. A total dose between 0.5 and 5 x106 cell/Kg will be administered in 3 administrations (fractions): |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARI0003 | Genetic | Treatment with ARI0003 cells |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of > grade 3 CRS and/or ICANS | Rate of patients who develop grade > 3 cytokine release syndrome (CRS) and/or grade > 3 immune cell associated neurotoxicity syndrome (ICANS) according to the criteria and grading defined in the international consensus document of the American Society for Transplantation and Cellular Therapy (ASTCT criteria). ASTCT score can be between 1 and 4 (being 1 the minimum value and 4 the maximum) and where higher score means worse outcome. | in the first 30 days after ARI0003 administration |
| ORR | Overall response rate (ORR) according to Lugano criteria (best response within 3 months post ARI0003 infusion | within 3 months post ARI0003 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related mortality (PRM) | Procedure-related mortality (PRM), defined as any death not directly cause by the lymphoma that is related with the procedure. For the estimation of PRM, disease relapse will be considered as a competing event | through study completion, an average of 24 months |
| Toxicity: incidence of AE |
Not provided
Inclusion Criteria:
1. Diagnosis of CD19+ or CD269+ relapsed/refractory (R/R) aggressive B-cell lymphoma in one of the following circumstances:
Burkitt's lymphoma;
Histology not covered by approved CART19-cell products (plasmablastic lymphoma, primary effusion lymphoma, intravascular lymphoma, transformed lymphoma from marginal zone lymphoma or chronic lymphocytic leukaemia, primary cutaneous DLBCL, T-cell rich DLBCL, high-grade B-cell lymphoma, grey zone lymphoma or grade 3b follicular lymphoma); or
Aggressive B-cell lymphoma that is refractory or relapsing after treatment with CART19-cell therapy.
2. Age older than 18 years. 3. ECOG performance status of 0-2. 4. Estimated life expectancy of at least 3 months. 5. Adequate venous access and absence of contraindications for lymphapheresis. 6. Signature of informed consent. 7. In patients who have received any anti-CD19 or anti-CD269 therapy (e.g. tisagenlecleucel, axicabtagene autoleucel, tafasitamab, loncastuximab, belantamab mafodotin, idecabtagene vicleucel, etc.), a centralised tumour sample confirming the expression of at least one of the antigens (either CD19 or CD269) will be needed at study inclusion
Exclusion Criteria:
1. Any experimental or non-commercialized therapy in the previous 4 weeks. 2. Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma.
3. Active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent).
4. Active infection requiring systemic medical therapy. 5. Active HBV or HCV infection. 6. Positive serology for HIV. 7. Any concomitant and uncontrolled medical disease. 8. Severe organic impairment defined by cardiac ejection fraction <40%, DLCO <40%, GFR <30 ml/min or bilirubin >3 times the upper limit of normality (unless due to Gilbert's syndrome).
9. Lactating or pregnant women. 10. Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures from the beginning until the end of the study.
11. CNS disease in the form of a macroscopic solid lesion in the encephalon or spinal cord (isolated meningeal disease is allowed
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julio Delgado, MD PhD | Contact | +34932275400 | jdelgado@clinic.cat | |
| Sara Varea, MSc | Contact | +34932275400 | svarea@clinic.cat |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Santiago de Compostela | Santiago de Compostela | A Coruña | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39563035 | Derived | Bachiller M, Barcelo-Genestar N, Rodriguez-Garcia A, Alserawan L, Dobano-Lopez C, Gimenez-Alejandre M, Castellsague J, Colell S, Otero-Mateo M, Antonana-Vildosola A, Espanol-Rego M, Ferruz N, Pascal M, Martin-Antonio B, Anguela XM, Fillat C, Olesti E, Calvo G, Juan M, Delgado J, Perez-Galan P, Urbano-Ispizua A, Guedan S. ARI0003: Co-transduced CD19/BCMA dual-targeting CAR-T cells for the treatment of non-Hodgkin lymphoma. Mol Ther. 2025 Jan 8;33(1):317-335. doi: 10.1016/j.ymthe.2024.11.028. Epub 2024 Nov 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Toxicity defined as the incidence of grade >3 adverse events (AEs) as per CTCAE version 5.0. The following AEs will be considered AEs of special interest (AESI): CRS, ICANS, macrophagic activation syndrome (MAS), tumour lysis syndrome (TLS), prolonged cytopenia (beyond 6 months), infections and second primary malignancies |
| at 3 and 12 months |
| Complete response rate | Complete response rate | at 3 months |
| Duration of response, | Duration of response, calculated from the time of first disease evaluation (3 months); | from month 3 to study completion, an average of 24 months |
| Progression-free survival | Progression-free survival, calculated from ARI-0003 cell infusion | through study completion, an average of 24 months |
| Overall survival | Overall survival, calculated from ARI-0003 cell infusion | through study completion, an average of 24 months |
| Hospital Clínic Barcelona | Barcelona | 08036 | Spain |
|
| H. Ramon y Cajal | Madrid | Spain |
|
| H.U. Virgen de la Arrixaca | Murcia | Spain |
|
| Hospital Central de Asturias | Oviedo | Spain |
|
| Hospital Son Espases | Palma de Mallorca | Spain |
|
| H. Clínico de Salamanca | Salamanca | Spain |
|
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided