The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR039 in treatment of relapsed or refractory NHL patients
This study plans to enroll 25 patients to assess the safety and efficacy of C-CAR039. Subjects who meet the eligibility criteria will receive a single dose of C-CAR039 injection. The study will include the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Bridging (if needed), Baseline, lymphodepletion, C-CAR039 infusion, and Follow-up Visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
Incidence and severity of adverse events
Incidence and severity of adverse events after CAR-T infusion
Time frame: Up to 12 weeks after C-CAR039 infusion
Overall Response rate (ORR)
Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria
Time frame: Up to 24 Months after C-CAR039 infusion
Duration of response (DOR)
The time from the date of first response (PR or CR) to the date of disease progression or death after C-CAR039 infusion
Time frame: Up to 24 Months after C-CAR039 infusion
Progression-free survival (PFS)
The time from C-CAR039 infusion to the date of progression as assessed by Lugano 2014 criteria or death
Time frame: Up to 24 Months after C-CAR039 infusion
Overall survival (OS)
The time from C-CAR039 infusion to the date of death
Time frame: Up to 24 Months after C-CAR039 infusion
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