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.
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.
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.
Single group
ARI0003
GeneticTreatment with ARI0003 cells
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.
ORR
Overall response rate (ORR) according to Lugano criteria (best response within 3 months post ARI0003 infusion
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
Toxicity: incidence of AE
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
Complete response rate
Complete response rate
Duration of response,
Duration of response, calculated from the time of first disease evaluation (3 months);
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This trial is not recruiting at the moment. You can still explore other options:
