IMMUNOTHERAPY WITH DIFFERENTIATED T CELLS, ADULTS, AUTOLOGOUS, FROM PERIPHERAL BLOOD, SELECTED BY CD62L EXPRESSION, EXPANDED AND TRANSDUCED (GENETICALLY MODIFIED) THROUGH A LENTIVIRAL VECTOR TO EXPRESS A CHIMERIC RECEPTOR WITH ANTI-CD19 SPECIFICITY ASSOCIATED WITH CO-STIMULATORY SEQUENCES 4-1-BB AND CD3Ζ IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA.

Trial details

Who runs it

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Trial code

EU 2024-519790-19-00

Record updated

2025. szeptember 29.

Original description

Evaluate the safety, toxicity, and efficacy of the administration of autologous memory T cells, mature, expanded ex vivo and genetically modified with a chimeric antigen receptor (CAR) targeting the CD19 antigenRead full original descriptionShow less

Evaluate the safety, toxicity, and efficacy of the administration of autologous memory T cells, mature, expanded ex vivo and genetically modified with a chimeric antigen receptor (CAR) targeting the CD19 antigen

Inclusion: Age > 18 years; All patients must have measurable disease (detected by PET-CT or CT) at the time of inclusion; Patients with Diffuse Large B-Cell Lymphoma (DLBCL): Histological diagnosis (WHO) of LDCGB or grade 3B follicular lymphoma, and Relapsed or refractory to 2 lines of treatment (including doxorubicin and anti-CD20 monoclonal antibody) or relapse after autologous hematopoietic stem cell transplantation from peripheral blood; Patients with Mantle Cell Lymphoma (MCL): Histological diagnosis (WHO) of MCL, including classical and blastoid variants, and Relapsed or refractory after two lines of treatment, which must include an anti-CD20 monoclonal antibody and a BTK inhibitor, or relapse after an autologous hematopoietic stem cell transplantation in patients who previously received a BTK inhibitor; Patients with Follicular Lymphoma (FL): Histological diagnosis (WHO) of FL grade 1-3a, and Relapsed or refractory to two lines of treatment (including anti-CD20 monoclonal antibody) or meet the criteria for early relapse (POD24) within the first 24 months after the start of initial treatment: relapse/refractoriness after one treatment (including anti-CD20 monoclonal antibody) or relapse after autologous hematopoietic stem cell transplantation; General condition according to ECOG scale: 0-2; FEV1 > 40%; DLCO and FVC > 40% of the predicted normal values; Absence of significant ventricular dysfunction: left ventricular ejection fraction > 40%; Total bilirubin and transaminases < 4 times the upper normal limit, unless attributable to lymphoma; Creatinine < 2 times the upper normal limit and clearance > 40 mL/min; Negative serology for HIV, HBV, and HCV. For patients with positive serology for HBV or HCV, a viral load of 0 must be confirmed via quantitative PCR; Absence of uncontrolled active bacterial, viral, or fungal infection; All patients must sign an informed consent form prior to the initiation of any procedure.

Exclusion: Presence of active autoimmune or rheumatologic disease requiring systemic treatment with any immunosuppressor; Major surgery within 6 weeks prior to inclusion; Any concomitant anticancer treatment; Active CNS infiltration by lymphoma. Previous lymphoma infiltration is not exclusionary if there is evidence of absence of disease in the CNS prior to treatment; Patients with concomitant severe neurological or psychiatric disease; General condition determined by ECOG scale: 3-4; Lung disease of any type that results in a DLCO < 40%; Active infection with HBV or HCV; HIV infection; Uncontrolled active bacterial, fungal, or viral infection; Abnormal renal and hepatic function, with creatinine and/or bilirubin levels more than 2 and 4 times higher than the normal limit, respectively, except when the abnormalities are attributable to lymphoma (only in cases of hepatic alteration); Patients with a left ventricular ejection fraction (LVEF) less than 40%, symptomatic heart failure, or both; Pregnant or breastfeeding patients; Presence of cirrhosis.

EU CTIS 2024-519790-19-00