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

Shanghai Jiao Tong University

Status: Active, not recruiting

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

Treatments: Drug: CNCT-19

Study type: Observational

Funder types: Other

Identifiers

NCT07269587

CN-ALL RWS001

Details and patient eligibility

About

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.

Enrollment: 275 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

275 participants in 1 patient group

observation group

Treatment:

Drug: CNCT-19