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

NCT ID: NCT07269587

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 275 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-07
• Study Completion Date: 2027-11-30

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

observation group

CNCT-19

Intervention Type: DRUG

All patients have received CNCT-19

Interventions

CNCT-19

All patients have received CNCT-19

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Wang

chief physician, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CN-ALL RWS001

Identifier Type: -

Identifier Source: org_study_id