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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Treatment with ARI0003 cells
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
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.
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 24 months
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
Time frame: at 3 and 12 months
Complete response rate
Complete response rate
Time frame: at 3 months
Duration of response,
Duration of response, calculated from the time of first disease evaluation (3 months);
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Hospital Central de Asturias
Oviedo, Spain
Hospital Son Espases
Palma de Mallorca, Spain
H. Clínico de Salamanca
Salamanca, Spain
Time frame: from month 3 to study completion, an average of 24 months
Progression-free survival
Progression-free survival, calculated from ARI-0003 cell infusion
Time frame: through study completion, an average of 24 months
Overall survival
Overall survival, calculated from ARI-0003 cell infusion
Time frame: through study completion, an average of 24 months