Clinical Trials in China / NCT07269587
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
Condition(s) studied
ALL (Acute B-Lymphoblastic Leukemia)CAR-T Cell Therapy
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality |
More Ruijin Hospital trials in China
A Follow-up Study of Asymptomatic Infections and Diagnosed Patients With Covid-19 in Shanghai
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TRIM25 in Septic Patients
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Other trials for the same condition
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