This is a single arm, open-label, early phase I study, to determine the safety and efficacy of Novel CAR-T cell therapy in Hematological Malignancy treatment.
The Novel CAR-T contains either a scFv plus a PD-L1 blocker, or two scFvs, in a cytokine complex based outer memberane structure, this kind of structure enables the CAR-T cells to simultaneously target one or two targets on the tumor cell surface and enhance CAR-T cell persistence in tumor microenvironment,as well as stimulating innate T/NK cell activation and expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of Novel CAR-T cells
Hunan Provincial People's Hospital
Changsha, Hunan, China
RECRUITINGsafety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)
Incidence of treatment-related adverse events as assessed by CTCAE v4.03
Time frame: 3 months
Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)
Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
Time frame: 3 months
Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria)
Partial response rate per the revised International Working Group (IWG) Response Criteria
Time frame: 3 months
Duration of Response (The time from response to relapse or progression)
The time from response to relapse or progression
Time frame: 24 months
Progression Free Survival (The time from the first day of treatment to the date on which disease progresses)
The time from the first day of treatment to the date on which disease progresses
Time frame: 24 months
Overall Survival (The number of patient alive, with or without signs of cancer)
The number of patient alive, with or without signs of cancer
Time frame: 24 months
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