CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).

Last updated: April 19, 2024
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Treatment

Venetoclax

Azacitidine Injection

CD19CD22 CAR-T

Clinical Study ID

NCT06078306
High Risk B-ALL
  • Ages 18-65
  • All Genders

Study Summary

Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age≥18 and ≤65 years old
  2. Newly diagnosed and high risk B-ALL according to the 2022 WHO classification
  3. The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;
  4. Anticipated survival time more than 12 weeks;
  5. Those who voluntarily participated in this trial and provided informed consent.

Exclusion

Exclusion Criteria:

  1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascularischemia, and cerebrovascular hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severearrhythmia in the past;
  3. Pregnant (or lactating) women;
  4. Patients with severe active infections (excluding simple urinary tract infection andbacterial pharyngitis);
  5. Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus orhepatitis C virus
  6. Previously treated with any CAR-T cell product or other genetically-modified T celltherapies;
  7. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
  8. Other uncontrolled diseases that were not suitable for this trial;
  9. Any situations that the investigator believes may increase the risk of patients orinterfere with the results of study.

Study Design

Total Participants: 20
Treatment Group(s): 3
Primary Treatment: Venetoclax
Phase: 2
Study Start date:
April 20, 2024
Estimated Completion Date:
September 10, 2025

Study Description

To evaluate the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in Adult patients with newly diagnosed high-risk and Ph- B-ALL in this prospective, single arm study.

Connect with a study center

  • Xiaowen Tang

    Suzhou, Jiangsu 215000
    China

    Active - Recruiting

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