This is a single arm, open-label, early phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Non-Hodgkin lymphoma treatment.
CD19-TriCAR contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the CD19-TriCAR-T/SILK to simultaneously targeting the CD19 positive Non-Hodgkin lymphoma,blocking the inhibitory PD-L1 signal and stimulating innate T/NK cell activation and expansion, thus make it a tri-functional CAR (Tri-CAR). CD19-TriCAR-T is an autologous tri-functional CAR-T cell therapy, CD19-TriCAR-SILK is an Allogeneic tri-functional CAR-NK cell therapy, patients ineligible for leukapheresis or CAR-T therapy will be recommended for CD19-TriCAR-SILK therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of CD19-TriCAR-T cells or 4 repeat infusions of CD19-TriCAR-SILK cells.
Hainan Cancer Hospital
Haikou, Hainan, China
RECRUITINGHainan General Hospital
Haikou, Hainan, China
RECRUITINGThe Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 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: 24 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: 24 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: 24 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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