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 CD3 IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA.
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase I-II
PATOLOGÍA
Leucemia linfática crónica y otros SLPC, Leucemia linfoblástica aguda, Leucemia mieloide aguda, Linfoma Hodgkin, Linfoma no Hodgkin, Terapia celular y T-CARs, Trasplante de progenitores hematopoyéticos, Linfoma Folicular, Linfoma
FECHA DE APERTURA
Julio, 2022
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
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.
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.
CRITERIOS DE EXCLUSIÓN
General condition determined by ECOG scale: 3-4.
Presence of active autoimmune or rheumatologic disease requiring systemic treatment with any immunosuppressor.
Lung disease of any type that results in a DLCO < 40%.
Major surgery within 6 weeks prior to inclusion.
Any concomitant anticancer treatment.
Pregnant or breastfeeding patients.
Active infection with HBV or HCV.
HIV infection.
Uncontrolled active bacterial, fungal, or viral infection.
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.
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.
Presence of cirrhosis.
Patients with concomitant severe neurological or psychiatric disease.
Presence of active autoimmune or rheumatologic disease requiring systemic treatment with any immunosuppressor.
Lung disease of any type that results in a DLCO < 40%.
Major surgery within 6 weeks prior to inclusion.
Any concomitant anticancer treatment.
Pregnant or breastfeeding patients.
Active infection with HBV or HCV.
HIV infection.
Uncontrolled active bacterial, fungal, or viral infection.
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.
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.
Presence of cirrhosis.
Patients with concomitant severe neurological or psychiatric disease.
DESCRIPCIÓN
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
PALABRAS CLAVE
acute lymphoblastic leukemia, acute myeloid leukemia, autologous, cd19, donor lymphocyte infusion, emr, follicular lymphoma, gene therapy, hodgkin, hodgkin lymphoma, leucemia linfocítica crónica (llc / cll), lymphoma, mantle cell lymphoma, non-hodgkin lymphoma, ph + acute lymphoblastic leukemia, philadelphia positive acute lymphoblastic leukemia
