Immunotherapy with differentiated T lymphocytes genetically modified in patients with classic Hodgkin's lymphoma and non-Hodgkin's lymphoma T with CD30 expressio
- Conditions
- Classic Hodgkin lymphoma and T-cell lymphoma with CD30 expressionTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2019-001263-70-ES
- Lead Sponsor
- Institut de Recerca H. de la Santa Creu i Sant Pau
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 30
Patients with classic Hodgkin's disease:
- Age between 18-70 years inclusive.
- Patients in relapse after an autologous hemopoietic stem cell transplant and who have previously received brentuximab and anti-PDL1 antibodies in some of the rescue treatments, without reaching RC.
- Patients who are primarily refractory (after the 1st line of treatment) and who do not reach RC after rescue treatments that include brentuximab and anti-PDL1 antibodies.
Patients with anaplastic large cell lymphoma T (ALK + and ALK -) and peripheral T lymphoma (NOS and angioimmunoblastic):
- Expression of CD30 (determined by immunohistochemistry) in> 90% of tumor cells for peripheral T-lymphoma.
- Age between 18-70 years inclusive.
- Patients in relapse after an autologous hemopoietic stem cell transplant.
- Patients who are primarily refractory (after the 1st line of treatment that includes anthracycline) who do not achieve CR after rescue chemotherapy (ESHAP, ICE, DHAP, Gemex, or brentuximab vedotin).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
- General condition determined according to the ECOG scale: 2-4
- Previous allogeneic hemopoietic transplant
- Active infection by HBV or HCV.
- HIV infection.
- Bacterial, fungal or viral active infection.
- Active infiltration of the CNS by lymphoma. Previous infiltration by lymphoma is not exclusive if there is evidence of absence of disease in the CNS prior to treatment.
- Abnormal renal and hepatic functions, with a creatinine and / or bilirubin figure 2 and 3 times higher than the normal limit value, respectively, except when the alterations are attributable to the lymphoma (only in case of hepatic alliteration).
- Patients with decreased ejection fraction (less than 45%), symptomatic heart failure, or both.
- Presence of cirrhosis or active hepatitis due to HBV or HCV virus.
- Patients with concomitant severe neurological or psychiatric disease.
- Presence of active autoimmune or rheumatological disease that requires systemic treatment with any immunosuppressant (including prednisone at any dose).
- Pneumopathy of any kind that conditions a DLC <50%
- Major surgery in the 6 weeks prior to the start of inclusion.
- Any concomitant antineoplastic treatment.
- Pregnancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and toxicity of the administration of autologous, mature, ex vivo expanded and genetically modified T lymphocytes with a chimeric antigen-specific receptor (CAR) directed against the CD30 antigen.;<br> Secondary Objective: - Analyze the implant and persistence of T-CAR30 cells.<br> - Analyze the rate of complete answers at 3 months of the procedure, using PET-CT.<br> - Analyze the impact of the procedure on 1-year progression-free survival.<br> ;<br> Primary end point(s): -Dose-limiting dose<br> -Security<br> -Response<br> ;Timepoint(s) of evaluation of this end point: Time to event
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): -Implant and persistence of HSP-CAR30 cells.<br> -Free progression survival.<br> -Global survival<br> ;Timepoint(s) of evaluation of this end point: Time to event