Immunotherapy with differential, adult, autologous, peripheral blood cells, expanded and transduced (genetically modified) using a lentiviral vector to express a chimeric receptor with anti-CD30 specificity associated with costimulatory sequences 4-1-BB and CD3z in patients with Classical Hodgkin's lymphoma and non-Hodgkin's lymphoma T with CD30 expression

Institut de Recerca H. de la Santa Creu i Sant Pau0 个研究点目标入组 30 人开始时间: 2019年8月9日最近更新: 2020年3月11日

适应症

试验速览

暂无简介。

•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.

发起方

Institut de Recerca H. de la Santa Creu i Sant Pau