HSP-CAR30 for Classical Hodgkin lymphoma | CD30+ non-Hodgkin T-cell lymphoma (relapsed or refractory)

Inclusion criteria

• {"criterion_text":"- All patients must sign informed consent before the start of any procedure.\n- General status according to ECOG scale: 0-1.\n- FEV1 > 39%; DLCO and FVC > 39% of normal theoretical values.\n- Absence of significant ventricular dysfunction: left ventricular ejection fraction >40%.\n- Total bilirubin and transaminases < 3 times the maximum normal value, unless attributable to lymphoma.\n- Creatinine < 2 times the maximum normal value and clearance > 40 mL/min.\n- 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\n- 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.\n- All patients must have measurable disease (detected by PET-CT) at the time of inclusion.\n- Patients with classic Hodgkin's disease: 1. Age 18-80 years or older\n- Patients with classic Hodgkin's disease: 2. Patients in relapse after an autologous transplant of hemopoietic progenitors and who have previously received brentuximab vedotin and anti-PDL1 antibodies in any of the rescue treatments, without achieving CR.\n- 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.\n- 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\n- Patients with anaplastic large cell T lymphoma (ALK + and ALK -) and peripheral T lymphoma (NOS and angioimmunoblastic): 2. Age 18 years or older\n- 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.\n- 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 criteria

• {"criterion_text":"- General condition determined according to ECOG scale: 2-4.\n- Presence of cirrhosis or active hepatitis due to HBV or HCV virus\n- Patients with concomitant severe neurological or psychiatric illness\n- Presence of active autoimmune or rheumatologic disease requiring systemic treatment with any immunosuppressant (including prednisone at any dose).\n- Pneumopathy of any type that causes a DLC <39%\n- Major surgery in the 6 weeks prior to the start of inclusion.\n- Any concomitant antineoplastic treatment.\n- Pregnant or lactating patients.\n- 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.\n- 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.\n- 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.\n- Previous allogeneic hemopoietic transplant within 12 weeks prior to screening.\n- Presence of acute graft-versus-receptor disease (GVHD) or chronic GVHD requiring immunosuppressive treatment of any type\n- Active HBV or HCV infection\n- HIV infection\n- Active, clinically relevant bacterial, fungal or viral infection.\n- 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.\n- 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).\n- Patients with decreased ventricular ejection fraction (FEV) (less than 40%), symptomatic heart failure, or both"}

Primary endpoints

• {"endpoint_text":"- Dose-limiting toxicity (DLT): the proportion of patients with DLT in the first month after infusion of HSP-CAR30 cells will be calculated, for each dose, together with the 95% confidence interval.","definition_or_measurement_approach":"DLT proportion measured in the first month after HSP-CAR30 infusion for each dose level; results reported with 95% confidence interval."}
• {"endpoint_text":"- Safety: Data on the type and frequency of AEs will be collected for each dose level, starting from the infusion of HSP-CAR30 cells and up to 30 days thereafter.","definition_or_measurement_approach":"Collection and reporting of type and frequency of adverse events for each dose level from infusion up to 30 days post-infusion."}
• {"endpoint_text":"- Answer: the percentage of responses (RC, RP and RG) will be analyzed according to RECIL 2017 criteria and its 95% confidence interval will be calculated. Only patients who receive the infusion of HSP-CAR30 cells will be evaluable for response. In no case will patients who do not present detectable disease by PET-CT (patient in CR), determined in the 30 days prior to the infusion of HSPCAR30 cells, be considered for response analysis.","definition_or_measurement_approach":"Response rates (CR, PR and SD or other RECIL 2017 categories) assessed per RECIL 2017 criteria among patients who received HSP-CAR30 infusion; percentages reported with 95% confidence intervals. Patients without measurable disease on PET-CT in the 30 days prior to infusion are not included in response analysis."}

Spain

Earliest CTIS Part Ii Submission Date

19-06-2024

Latest Decision Or Authorization Date

29-08-2025

Processing Time Days

436

Number Of Sites

1

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