This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or leukemia.
Anti- CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD5 antigen. CD5+ T cell lymphomas or leukemia are a subset of leukemias and lymphomas that are positive for the surface protein CD5. The purpose of this study is to evaluate the efficacy and safety of anti-CD5 CAR T cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
RECRUITINGNumber of adverse events after anti-CD5 CAR T cells cell infusion
Determine the toxicity profile of anti-CD5 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)
Time frame: up to 2 years
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Time frame: up to 2 years
Overall Survival (OS)
Overall Survival (OS)
Time frame: up to 2 years
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