This open-label, multi-cohorts, phase 1/2 study has the primary objective of comparing decitabine-primed tandem CART 19/20 solo, with decitabine-primed tandem CART 19/20 plus chidamide, decitabine-primed tandem CART 19/20 plus decitabine, and decitabine-primed tandem CART 19/20 plus decitabine+chidamide in patients with aggressive B-NHL who were confirmed as Relapsed and/or Refractory B cell Non-Hodgkin's Lymphoma with hugh tumor burden (Sum of the Product of the perpendicular Diameters for multiple lesions, SPD ≥ 100cm\^2 or the largest-diameter of tumor ≥ 10 cm.).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Chidamide will be added 1 month after responding to CART cells infusion
Decitabine will be added 1 month after responding to CART cells infusion
Both chidamide and decitabine will be added 1 month after responding to CART cells infusion
Tandem CAR19/20 engineered T cells
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGAdverse events after intervention
Safety Outcome
Time frame: 12 months
Progression Free Survival
Time frame: 2 years
Duration of Response
Time frame: 2 years
Overall Survival
Time frame: 2 years
Objective Response Rate Outcome Measure
ORR assess by investigators per the 2014 Lugano classification rate of subjects achieved objective response in all evaluable subjects
Time frame: 2 years
Intervention treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0
Time frame: 12 months
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