SNPMiner Trials (Home Page)
Report for Clinical Trial NCT04034446
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
CD19-CD22 CAR-T cells in patients with CD19+CD22+ Leukemia.
Name: CD19-CD22 CAR-T cells
Description: 0.5 to 3.0 x 106 autologous CD19-CD22 CAR-T cells per kg body weight, with a maximum dose of 4 x 108 autologous CD19-CD22 CAR-T 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 days Time: 1 month
Measure: Percentage of patients who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at month 6 without SCT between CD19-CD22 CAR-T cells infusion and Month 6 response assessment. Time: 6 months
Measure: Percentage of patients who achieve CR or CRi with minimal residual disease (MRD) negative bone marrow Time: 6 months
Measure: Relapse-free survival (RFS) Time: 24 months
Measure: Duration of remission (DOR) Time: 24 months
Measure: Overall survival (OS) Time: 24 months
Purpose: Treatment
Allocation: N/A
Single Group Assignment
There is one SNP
SNPs
1 T315I
5. Without remission or relapse after any prior CD19 targeted therapy;
6. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are
intolerant to or have failed 2 lines 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 ---
5. Without remission or relapse after any prior CD19 targeted therapy;
6. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are
intolerant to or have failed 2 lines 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 ---
HPO Nodes
HPO: