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Not yet recruiting NCT06097455

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

Early Phase I Interventional Refractory Non-Hodgkin Lymphoma Relapsed Non-Hodgkin Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARI0003.
Who it may be relevant to
Registry conditions: Refractory Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

First in Human, Pilot, Open-label, Prospective, Multicentre, Non-randomised Clinical Trial to Evaluate the Safety and Efficacy of ARI0003 (CART CD19/ CD269 Cells) in Patients With Relapsed/Refractory B-cell Aggressive Lymphoma

Overview

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.

Interventions

  • Genetic ARI0003
    Treatment with ARI0003 cells

Primary outcome measures

  • Rate of > grade 3 CRS and/or ICANS [Time frame: in the first 30 days after ARI0003 administration]
  • ORR [Time frame: within 3 months post ARI0003 infusion]
Secondary outcome measures (6)
  • Procedure-related mortality (PRM) [Time frame: through study completion, an average of 24 months]
  • Toxicity: incidence of AE [Time frame: at 3 and 12 months]
  • Complete response rate [Time frame: at 3 months]
  • Duration of response, [Time frame: from month 3 to study completion, an average of 24 months]
  • Progression-free survival [Time frame: through study completion, an average of 24 months]
  • Overall survival [Time frame: through study completion, an average of 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 7 centers
  • CHU Santiago de Compostela — Santiago de Compostela
  • Hospital Clínic Barcelona — Barcelona
  • H. Ramon y Cajal — Madrid
  • H.U. Virgen de la Arrixaca — Murcia
  • Hospital Central de Asturias — Oviedo
  • Hospital Son Espases — Palma de Mallorca
  • H. Clínico de Salamanca — Salamanca

Publications

  • 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 PMID 39563035

Identifiers

NCT: NCT06097455 · CARTD-BG-1 · 2023-5072-13-97-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗