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Report for Clinical Trial NCT04034446

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

a Feasibility and Safety Study of Bispecific CD19-CD22 CAR-T Cell in the Treatment of Relapsed or Refractory B-ALL

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.

NCT04034446 Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
MeSH:Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
HPO:Leukemia Lymphoid leukemia

1 Interventions

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
Group Labels: 1

A


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: