2024-515624-36-00Active, not recruitingPhase 1/2
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Sept 2026
Brief summary (registry, in English)
To evaluate the safety and toxicity of HSP-CAR30 cell administration.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 9 Dec 2024
- Start date
- 17 Dec 2024
- Lead sponsor
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Diseases
- Hodgkin lymphoma
- EU CT number
- 2024-515624-36-00
- EudraCT number
- 2019-001263-70
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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
Other
- Pneumopathy of any type that causes a DLC <39%
- Pregnant or lactating patients.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.