This is a single arm, open-label, single center study to determine the safety and efficacy of CNCT19 in adult patients with Relapsed or Refractory B cell Malignancies.
This is a single arm, open-label, single-center study to determine the safety and efficacy of CNCT19 in adult patients with r/r B cell Malignancies. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CNCT19 cell infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
0.5 to 4 x 10\^6 autologous CNCT19 transduced cells per kg body weight, with a maximum dose of 4 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion.
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 24 months
Overall remission rate (ORR)
Time frame: 3 months
Response at Day 28±3 days
Time frame: 1 month
Percentage of patients who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) (partial remission,PR) at month 6 without SCT between CNCT19 infusion and Month 6 response assessment.
Time frame: 6 months
Percentage of patients who achieve CR or CRi (PR) with minimal residual disease negative bone marrow.
Time frame: 6 months
Relapse-free survival
Time frame: 24 months
Progression-free survival
Time frame: 24 months
Percentage of patients who achieve best overall response (BOR)
Time frame: 24 months
Duration of remission (DOR)
Time frame: 24 months
Overall survival
Time frame: 24 months
Percentage of patient who achieve CR or CRi (PR) and then proceed to stem cell transplantation(SCT) while in remission.
Time frame: 24 months
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Proportion of patients with detectable replication competent lentivirus (RCL) by vesicular stomatitis virus, glycoprotein (VSV-G)
Time frame: at Month 3 post treatment then Month 6 and Month12, yearly until year 15 if CD19 chimeric antigen receptor (CAR) transgene is still detected