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Report for Clinical Trial NCT04011293
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
Name: CNCT19
Description: 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.
Type: Biological
Primary Outcomes
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Time: 24 months
Measure: Overall remission rate (ORR) Time: 3 months
Secondary Outcomes
Measure: Response at Day 28±3 days Time: 1 month
Measure: 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: 6 months
Measure: Percentage of patients who achieve CR or CRi (PR) with minimal residual disease negative bone marrow. Time: 6 months
Measure: Relapse-free survival Time: 24 months
Measure: Progression-free survival Time: 24 months
Measure: Percentage of patients who achieve best overall response (BOR) Time: 24 months
Measure: Duration of remission (DOR) Time: 24 months
Measure: Overall survival Time: 24 months
Measure: Percentage of patient who achieve CR or CRi (PR) and then proceed to stem cell transplantation(SCT) while in remission. Time: 24 months
Measure: Proportion of patients with detectable replication competent lentivirus (RCL) by vesicular stomatitis virus, glycoprotein (VSV-G) Time: at Month 3 post treatment then Month 6 and Month12, yearly until year 15 if CD19 chimeric antigen receptor (CAR) transgene is still detected
Purpose: Treatment
Allocation: N/A
Single Group Assignment
There is one SNP
SNPs
1 T315I
- Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are
intolerant to or have failed 1generation and/or 2 generation of tyrosine kinase
inhibitor therapy (TKI); no TKI salvage treatments if the patient has a BCR-ABL1
kinase domain gatekeeper mutation Thr315Ile (T315I) mutation. --- Thr315Ile ---
- Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are
intolerant to or have failed 1generation and/or 2 generation of tyrosine kinase
inhibitor therapy (TKI); no TKI salvage treatments if the patient has a BCR-ABL1
kinase domain gatekeeper mutation Thr315Ile (T315I) mutation. --- Thr315Ile --- --- T315I ---