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Report for Clinical Trial NCT04230473

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia

This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of CNCT19 in adult patients with relapsed or refractory acute lymphoblastic leukemia.

NCT04230473 Relapsed or Refractory Acute Lymphoblastic Leukemia
MeSH:Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
HPO:Leukemia Lymphoid leukemia

1 Interventions

Name: single dose of CNCT19

Description: Dose A: 0.25 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide Dose B: 1.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide Dose C: 2.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
Type: Biological
Group Labels: 1

Single dose of CNCT19


Primary Outcomes

Description: Determine the MTD and DLT of CNCT19 in the Treatment and recommend the dose for Phase II study.

Measure: Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D)

Time: 28 days

Description: Safety measures include adverse events as assessed by CTCAE v5.0.

Measure: Safety of CNCT19 therapy

Time: 24 months

Secondary Outcomes

Description: Efficacy of CNCT19 as measured by ORR during the 3 months after CNCT19 infusion, which includes CR and CRi.

Measure: Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi)

Time: 3 months

Description: Description: ORR includes CR and CRi.

Measure: Overall Remission Rate (ORR)

Time: 28 days

Description: MRD negative status as determined by central laboratory using multi-parameter flow cytometry.

Measure: Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow

Time: 28 days

Description: MRD negative status as determined by central laboratory using multi-parameter flow cytometry.

Measure: Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow

Time: 3 months

Description: ORR includes CR and CRi.

Measure: Overall Remission Rate (ORR)

Time: 6 months

Description: MRD negative status as determined by central laboratory using multi-parameter flow cytometry.

Measure: Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow

Time: 6 months

Description: DOR is defined as the time from the first documented CR or Partial Remission (PR) to the date of the first documented progressive disease(PD) or death due to any cause.

Measure: Duration of remission (DOR)

Time: 24 months

Description: RFS is defined as the time from the documented CR or PR after the CNCT19 infusion to the date of the documented PD or death due to any cause.

Measure: Relapse-free survival (RFS)

Time: 24 Months

Description: OS is defined as the time from the signing of informed consent form to the date of the last survival follow-up or death due to any cause.

Measure: Overall survival (OS)

Time: 24 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T315I

5. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 1 generation and/or 2 generation of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a T315I mutation. --- T315I ---



HPO Nodes


HPO: