The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.
Name: single dose of CNCT19
Description: The Investigators' evaluation results of ORR will be subjected to sensitivity analysis.
Measure: Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) as determined by Independent Review Committee (IRC). Time: 3 monthsDescription: MRD negative status as determined using flow cytometry.
Measure: Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow as determined by IRC and Investigators. Time: 3 monthsDescription: The proportion of patients who have achieved CR or CRi.
Measure: Overall Remission Rate (ORR) as determined by IRC and Investigators. Time: 28 daysDescription: MRD negative status as determined using flow cytometry.
Measure: Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow as determined by IRC and Investigators. Time: 28 daysDescription: RFS means the duration from reaching the response CR or CRi to the first defined relapse, or death due to any cause, whichever comes first.
Measure: Relapse Free Survival (RFS) as determined by IRC and Investigators. Time: 2 yearsDescription: EFS means duration from the CNCT19 Cell Injection infusion to death for any reason after remission, relapse, treatment failure, no response, or termination (because of death, adverse event, lack of efficacy, progression, new anti-tumor treatments.
Measure: Event free survival (EFS) as determined by IRC and Investigators. Time: 2 yearsDescription: DOR means the duration from reaching the response CR or CRi to the first defined relapse, or death due to any cause, whichever comes first.
Measure: Duration of remission (DOR) as determined by IRC and Investigators. Time: 2 yearsDescription: The proportion of patients who have achieved the best effect (CR or CRi) after the experimental treatment.
Measure: Best overall response (BOR) as determined by IRC and Investigators. Time: 2 yearsDescription: OS is defined as the time from the CNCT19 Cell Injection infusion to the date of death due to any cause.
Measure: Overall survival (OS) as determined by IRC and Investigators. Time: 2 yearsDescription: Characterize the pharmacokinetic (PK) profile in blood, bone marrow (if available) and Cerebral Spinal Fluid (CSF) (if available) by qPCR.
Measure: In vivo cellular Pharmacokinetic (PK) profile of CNCT19 in units of transgene copy number per genomic DNA (gDNA) amount. Time: 2 yearsDescription: Characterize the pharmacokinetic (PK) profile in blood, bone marrow (if available) and Cerebral Spinal Fluid (CSF) (if available) by Flow Cytometry.
Measure: In vivo cellular Pharmacokinetic (PK) profile of CNCT19 in units of percent of CAR-positive cells. Time: 2 yearsDescription: Collected as pharmacodynamic data, including IL-6 at list.
Measure: Concentration of Cytokines in Serum. Time: 28 daysDescription: Collected as pharmacodynamic data.
Measure: Concentration of ferritin in Serum. Time: 28 daysDescription: Collected as pharmacodynamic data.
Measure: Concentration of C reactive protein in serum. Time: 28 daysDescription: Collected as Immunogenicity data.
Measure: Prevalence and incidence of humoral immunogenicity (anti-drug antibodies) to CNCT19. Time: 2 yearsAllocation: 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 2 generation of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a T315I mutation. --- T315I ---