First in Human Study of the Infusion of ARI0003 Cells in Relapsed/Refractory to Treatment B-cell Aggressive Lymphoma

NCT ID: NCT06097455

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2027-01-15

Brief Summary

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.

Conditions

Refractory Non-Hodgkin Lymphoma; Relapsed Non-Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARI0003

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):

Group Type: EXPERIMENTAL

ARI0003

Intervention Type: GENETIC

Treatment with ARI0003 cells

Interventions

ARI0003

Treatment with ARI0003 cells

Intervention Type: GENETIC

Other Intervention Names

Adult autologous differentiated T-cells from peripheral blood, expanded and co-transduced lentiviruses: one containing a chimeric antigen receptor anti-CD19 and another containing an anti-CD269 (BCMA)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Hospital Clínic Barcelona

Barcelona, , 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

Countries

Spain

Central Contacts

Julio Delgado, MD PhD

Role: CONTACT

jdelgado@clinic.cat

+34932275400

Sara Varea, MSc

Role: CONTACT

svarea@clinic.cat

+34932275400

Facility Contacts

Adrián Mosquera Orgeira, MD

Role: primary

Julio Delgado

Role: primary

jdelgado@clinic.cat

+34932275400

Javier Lopez Jiménez, MD

Role: primary

Jose M Moraleda, MD PhD

Role: primary

Jose M Garcia Gala, MD

Role: primary

Leyre Bento de Miguel, MD

Role: primary

Fermín Sanchez-Guijo

Role: primary

References

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.

Reference Type: DERIVED

PMID: 39563035 (View on PubMed)

Other Identifiers

2023-5072-13-97-00

Identifier Type: OTHER

Identifier Source: secondary_id

CARTD-BG-1

Identifier Type: -

Identifier Source: org_study_id