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.
Name: single dose of CNCT19
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 daysDescription: Safety measures include adverse events as assessed by CTCAE v5.0.
Measure: Safety of CNCT19 therapy Time: 24 monthsDescription: 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 monthsDescription: Description: ORR includes CR and CRi.
Measure: Overall Remission Rate (ORR) Time: 28 daysDescription: 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 daysDescription: 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 monthsDescription: ORR includes CR and CRi.
Measure: Overall Remission Rate (ORR) Time: 6 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 MonthsDescription: 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 monthsAllocation: N/A
Single Group Assignment
There is one SNP
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 ---