Inmmunotherapy with peripheral blood, autologous, a dult T cells, expanded and transduced (gene modified) with a lentiviral vector expressing an anti-CD30-chimeric antigen receptor with 4-1-BB and CD3z costimulatory sequences in patients with Classical Hodgkin lymphoma and non-Hodgkin CD30+ T cell lymphoma.

Trial details

Who runs it

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

Trial code

EU 2024-515624-36-00

Record updated

2026. szeptember 28.

Original description

To evaluate the safety and toxicity of HSP-CAR30 cell administration.Read full original descriptionShow less

To evaluate the safety and toxicity of HSP-CAR30 cell administration.

Inclusion: All patients must sign informed consent before the start of any procedure; General status according to ECOG scale: 0-1; FEV1 > 39%; DLCO and FVC > 39% of normal theoretical values; Absence of significant ventricular dysfunction: left ventricular ejection fraction >40%; Total bilirubin and transaminases < 3 times the maximum normal value, unless attributable to lymphoma; Creatinine < 2 times the maximum normal value and clearance > 40 mL/min; Negative serology for HIV, HBV and HCV. In the case of patients with positive serology for HBV or HCV, they must have a viral load of 0 measured by quantitative PCR; Absence of active, clinically relevant bacterial or viral infection. A diagnostic test for influenza virus, respiratory syncytial (nasopharyngeal aspirate) and SarsCov2 must be performed in ALL patients, prior to starting treatment, with a negative result; All patients must have measurable disease (detected by PET-CT) at the time of inclusion; Patients with classic Hodgkin's disease: 1. Age 18-80 years or older; Patients with classic Hodgkin's disease: 2. Patients with relapsed and/or refractory disease after at least three prior lines of therapy, including brentuximab vedotin and anti-PD-1 antibodies; Patients with classic Hodgkin's disease: 3. Primary refractory patients (after 1st line of treatment) and who do not achieve CR after rescue treatments that include brentuximab and anti-PDL1 antibodies; Patients with anaplastic large cell T lymphoma (ALK + and ALK -) and peripheral T lymphoma (NOS and angioimmunoblastic): 1. CD30 expression (determined by immunohistochemistry) in > 90% of tumor cells for peripheral T lymphoma; Patients with anaplastic large cell T lymphoma (ALK + and ALK -) and peripheral T lymphoma (NOS and angioimmunoblastic): 2. Age 18 years or older; Patients with anaplastic large cell T lymphoma (ALK + and ALK -) and peripheral T lymphoma (NOS and angioimmunoblastic): 3. Patients in relapse after an autologous transplant of hemopoietic progenitors; Patients with anaplastic large cell T lymphoma (ALK + and ALK -) and peripheral T lymphoma (NOS and angioimmunoblastic): 4. Primary refractory patients (after 1st line of treatment that includes anthracycline) who do not achieve CR after rescue chemotherapy (type ESHAP, ICE, DHAP, Gemox or brentuximab vedotin).

Exclusion: Patients with concomitant severe neurological or psychiatric illness; Presence of active autoimmune or rheumatologic disease requiring systemic treatment with any immunosuppressant (including prednisone at any dose); Major surgery in the 6 weeks prior to the start of inclusion; Any concomitant antineoplastic treatment; Previous or concurrent neoplasms. Except: basal cell or squamous cell carcinoma, history of carcinoma in situ with previous curative treatment, solid neoplasia with complete resection and in remission for >3 years; Before starting lymphodepleting chemotherapy, the following requirements (all) must be met: - absence of clinically relevant active bacterial, fungal or viral infection. Viral infections that must be evaluated before starting chemotherapy are: influenza virus, respiratory syncytial virus and SarsCov2, using a nasopharyngeal aspirate whose result is negative. - absence of antineoplastic treatment in the previous 2 weeks. - absence of treatment with corticosteroids (any dose), with the exception of hydrocortisone (maximum 10 mg/m2). - absence of treatment with G-CSF/GM-CSF. - absence of treatment with any immunosuppressant (calcineurin inhibition, mycophenolate, rapamycin, anti-IL-6 antibodies, methotrexate) in the previous 2 weeks; Previous allogeneic hemopoietic transplant within 12 weeks prior to screening; Active infiltration of the CNS by lymphoma. Previous infiltration by lymphoma is not exclusive if there is demonstration of absence of disease in the CNS prior to treatment; General condition determined according to ECOG scale: 2-4; Presence of cirrhosis or active hepatitis due to HBV or HCV virus; Presence of acute graft-versus-receptor disease (GVHD) or chronic GVHD requiring immunosuppressive treatment of any type; Active HBV or HCV infection; HIV infection; Active, clinically relevant bacterial, fungal or viral infection; Before starting lymphoapheresis, all of the following requirements must be met: - absolute lymphocyte count in peripheral blood > 100/ml. - absence of chemotherapy treatment in the previous 2 weeks. - absence of treatment with brentuximab in the last 2 months. - absence of treatment with anti-PD1 in the previous 6 weeks. - absence of treatment with corticosteroids (any dose), with the exception of hydrocortisone (maximum 10 mg/m2). - absence of treatment with G-CSF/GM-CSF. - absence of treatment with any immunosuppressant (calcineurin inhibition, mycophenolate, rapamycin, anti-IL-6 or IL-6R antibodies, methotrexate) in the previous 2 weeks; Abnormal kidney and liver functions, with creatinine and/or bilirubin levels 2 and 3 times higher than the normal limit value, respectively, except when the alterations are attributable to lymphoma (only in the case of liver alliteration); Patients with decreased ventricular ejection fraction (FEV) (less than 40%), symptomatic heart failure, or both; Pneumopathy of any type that causes a DLC <39%; Pregnant or lactating patients.

EU CTIS 2024-515624-36-00