A Real-world Study on the Treatment of Adult B-cell Acute Lymphoblastic Leukemia With CNCT-19

A Retrospective, Observational, and Multicenter Real-world Study on the Treatment of Adult B-cell Acute Lymphoblastic Leukemia With CNCT-19

This clinical study is a retrospective, observational, and multicenter post marketing real-world study aimed at evaluating the efficacy and safety of CNCT-19 in the treatment of Chinese adult B-cell acute lymphoblastic leukemia patients.

Study Overview

• Status: Active, not recruiting
• Conditions: ALL (Acute B-Lymphoblastic Leukemia); CAR-T Cell Therapy
• Intervention / Treatment: Drug: CNCT-19

• Study Type: Observational
• Enrollment (Actual): 275

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients received CNCT-19 treatment in all participant center of this study

Description

Inclusion Criteria:

1. Age ≥ 14 years old;
2. Diagnosed with CD19+B-cell acute lymphoblastic leukemia [refer to the Chinese Guidelines for Diagnosis and Treatment of Adult Acute lymphoblastic Leukemia (2024 edition)];
3. Patients who have received treatment with CNCT-19.

Exclusion Criteria:

1. Individuals with acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within the first 4 weeks of screening; Individuals who have received systemic drug therapy for GVHD within the past 4 weeks prior to reinfusion;
2. Active systemic autoimmune diseases during treatment;

3. Those who meet any of the following criteria:

   • Positive hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg);
   • hepatitis B e antibody (HBe Ab) and/or hepatitis B core antibody (HBc Ab) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit;
   • Hepatitis C antibody (HCV Ab) positive;
   • Positive for Treponema pallidum antibody (TP Ab);
   • Positive human immunodeficiency virus (HIV) antibody test;
   • EBV-DNA and CMV-DNA copy numbers are greater than the measurable lower limit;
4. Individuals known to have a history of hypersensitivity reactions to the components of the formulation used in the experiment.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
observation group	Drug: CNCT-19; All patients have received CNCT-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate(for R/R patients)	The proportion of patients who reach CR/CRi.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.	Till the end of the study, up to 24 months
minimal residual disease negativity rate(for MRD positive patients)	The proportion of patients who reach MRD negative in all patients reached CR/CRi.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.	Till the end of the study, up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DOR(Duration Of Remission)	Time from the first assessment of MRD negative to the first assessment of MRD positive or death from any cause.	till the end of the study, up to 24 months
rate of Allogeneic hematopoietic stem cell transplantation	The proportion of patients who receive allo-HSCT after CNCT19 treatment.	till the end of the study, up to 24 months
Relapse-free survival (RFS)	Interval from the date of treatment of the CNCT-19 to the time of hematological recurrence or death from any cause. Evaluation of RFS will be based on follow-up results.	till the end of the study, up to 24 months
Overall Survival(OS)	Interval from the date of the feedback to the time of death due to any reason. Evaluation of OS will be based on follow-up results.	till the end of the study, up to 24 months
incidence of Adverse Events(AEs)	The proportion of patients who have adverse events after CNCT-19 treatment.Adverse events will be assessed by CTCAE v5.0	up to 24 months
incidence of Severe Adverse Events(SAEs)	The proportion of patients who have severe adverse events after CNCT-19 treatment.Adverse events with one of the following damages should be classified as serious drug adverse events: Causing death;; Endangering life;; Causing hospitalization or prolonged hospitalization time;; Causing permanent or significant disability/loss of function;; Congenital abnormalities/birth defects;; Causing other important medical events that, if left untreated, may result in the situations listed above.	up to 24 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Estimated): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CN-ALL RWS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No