HSP-CAR19M for Diffuse large B-cell lymphoma | Mantle cell lymphoma | Follicular lymphoma

Inclusion criteria

• {"criterion_text":"- Age > 18 years\n- General condition according to ECOG scale: 0-2.\n- FEV1 > 40%; DLCO and FVC > 40% of the predicted normal values.\n- Absence of significant ventricular dysfunction: left ventricular ejection fraction > 40%.\n- Total bilirubin and transaminases < 4 times the upper normal limit, unless attributable to lymphoma.\n- Creatinine < 2 times the upper normal limit and clearance > 40 mL/min.\n- 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.\n- Absence of uncontrolled active bacterial, viral, or fungal infection.\n- All patients must sign an informed consent form prior to the initiation of any procedure.\n- All patients must have measurable disease (detected by PET-CT or CT) at the time of inclusion.\n- 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.\n- 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.\n- 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."}

Exclusion criteria

• {"criterion_text":"- General condition determined by ECOG scale: 3-4.\n- Active infection with HBV or HCV.\n- HIV infection.\n- Uncontrolled active bacterial, fungal, or viral infection.\n- 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.\n- 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).\n- Patients with a left ventricular ejection fraction (LVEF) less than 40%, symptomatic heart failure, or both.\n- Presence of cirrhosis.\n- Patients with concomitant severe neurological or psychiatric disease.\n- Presence of active autoimmune or rheumatologic disease requiring systemic treatment with any immunosuppressor.\n- Lung disease of any type that results in a DLCO < 40%.\n- Major surgery within 6 weeks prior to inclusion.\n- Any concomitant anticancer treatment.\n- Pregnant or breastfeeding patients."}

Primary endpoints

• {"endpoint_text":"- Safety associated with the infusion of HSP-CAR19M cells. In the expansion phase: evaluation of the safety and efficacy of HSP-CAR19M cell administration.","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

16-01-2025

Latest Decision Or Authorization Date

29-09-2025

Processing Time Days

256

Number Of Sites

2

Number Of Participants

40

Primary sponsor

Full Name

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

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain