This is a single arm, open-label, single-center, phase 1/2 study, to determine the safety and efficacy of TriCAR-T-CD19, an autologous tri-functional anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory/Relapsed Non-Hodgkin Lymphoma (NHL).
The tri-functional anti-CD19 chimeric antigen receptor contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the TriCAR-T-CD19 to simultaneously targeting the CD19 positive NHL,blocking the inhibitory PD-L1 signal and stimulating T/NK cell activation and expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously at a target dose of 0.5-1 x 10\^6 CAR+ T cells/kg
Hunan Provincial People's Hospital
Changsha, Hunan, China
RECRUITINGSafety (Incidence of treatment-related adverse events as assessed by CTCAE v4.0)
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 30 Days
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: 12 months
Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)
Partial response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
Time frame: 12 months
Duration of Response (The time from response to relapse or progression)
The time from response to relapse or progression
Time frame: 12 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: 12 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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