Ireland
--:--IST
Starting soon Early Phase 1

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

NCT06097455 · tracked via the Priya Life Science Spain tracker
Phase
Early Phase 1
Started
2024-01-15
Last updated
2023-10-26

Condition(s) studied

Refractory Non-Hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

ARI0003

ARI0003: Treatment with ARI0003 cells

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of > grade 3 CRS and/or ICANS — in the first 30 days after ARI0003 administration
    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.
  • ORR — within 3 months post ARI0003 infusion
    Overall response rate (ORR) according to Lugano criteria (best response within 3 months post ARI0003 infusion

Trial sites (7)

FacilityCityRegionStatus
CHU Santiago de Compostela Santiago de Compostela A Coruña
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06097455 on ClinicalTrials.gov ↗ ← All trials in Spain