Clinical trial · Observational
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
NCT07269587CI-TRIAL-00098770active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL (Acute B-Lymphoblastic Leukemia) | Acute Lymphoblastic Leukemia | ALIAS | 0.85 |
| CAR-T Cell Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CNCT-19 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- observation group
- interventionNames
- Drug: CNCT-19
Primary outcomes (2)
- measure
- overall response rate(for R/R patients)
- timeFrame
- Till the end of the study, up to 24 months
- description
- 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.
- measure
- minimal residual disease negativity rate(for MRD positive patients)
- timeFrame
- Till the end of the study, up to 24 months
- description
- 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 (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.