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NCT Number: NCT07269587

A 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

ALL (Acute B-Lymphoblastic Leukemia) CAR-T Cell Therapy

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • Active systemic autoimmune diseases during treatment;
  • 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;
  • Individuals known to have a history of hypersensitivity reactions to the components of the formulation used in the experiment.

Treatment and study plan

CNCT-19

Drug

All patients have received CNCT-19

Primary outcomes

  1. overall response rate(for R/R patients)

    Time frame: Till the end of the study, up to 24 months

    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.

  2. minimal residual disease negativity rate(for MRD positive patients)

    Time frame: Till the end of the study, up to 24 months

    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.

Secondary outcomes

  1. DOR(Duration Of Remission)

    Time frame: till the end of the study, up to 24 months

    Time from the first assessment of MRD negative to the first assessment of MRD positive or death from any cause.

  2. rate of Allogeneic hematopoietic stem cell transplantation

    Time frame: till the end of the study, up to 24 months

    The proportion of patients who receive allo-HSCT after CNCT19 treatment.

  3. Relapse-free survival (RFS)

    Time frame: till the end of the study, up to 24 months

    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.

  4. Overall Survival(OS)

    Time frame: till the end of the study, up to 24 months

    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.

  5. incidence of Adverse Events(AEs)

    Time frame: up to 24 months

    The proportion of patients who have adverse events after CNCT-19 treatment.Adverse events will be assessed by CTCAE v5.0

  6. incidence of Severe Adverse Events(SAEs)

    Time frame: up to 24 months

    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.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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