This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.
CD4-specific CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD4 antigen. CD4+ T cell lymphomas are a subset of leukemias and lymphomas that are positive for the surface protein CD4. The purpose of this study is to evaluate the efficacy and safety of CD4 CAR T cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CD4 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
RECRUITINGChengdu Military General Hospital
Chengdu, Sichuan, China
NOT_YET_RECRUITINGNumber of adverse events after CD4 CAR T cells cell infusion
Determine the toxicity profile of CD4 CAR T cell therapy
Time frame: 2 years particularly the first 28 days after infusion
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Time frame: up to 6 months
Disease Free Survival (DFS)
Disease Free Survival (DFS) (IMWG criteria)
Time frame: up to 2 years
Progression-Free Survival (PFS)
Progression-Free Survival (IMWG criteria)
Time frame: up to 2 years
Overall Survival (OS)
overall survival
Time frame: up to 2 years
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