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Active, not recruiting Observational

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

NCT07269587 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-11-07
Last updated
2025-12-10

Condition(s) studied

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

Investigational drug(s) / intervention(s)

CNCT-19 →

CNCT-19: All patients have received CNCT-19

Study summary

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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • overall response rate(for R/R patients) — 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.
  • minimal residual disease negativity rate(for MRD positive patients) — 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.

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07269587 on ClinicalTrials.gov ↗ ← All trials in China