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

NCT07269587 | Active Not Recruiting

• 1 other identifier: CN-ALL RWS001
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• DOR(Duration Of Remission)

  till the end of the study, up to 24 months

• rate of Allogeneic hematopoietic stem cell transplantation

  till the end of the study, up to 24 months

• Relapse-free survival (RFS)

  till the end of the study, up to 24 months

• Overall Survival(OS)

  till the end of the study, up to 24 months

• incidence of Adverse Events(AEs)

  up to 24 months

Study Arms (1)

observation group

Drug: CNCT-19

Interventions

CNCT-19 DRUG

All patients have received CNCT-19

observation group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician, MD, PhD

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CN (1)