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

Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06078306
Collaborator
(none)
20
Enrollment
1
Arm
23
Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Trial for the Safety and Efficacy of Induction Chemotherapy With Azacitidine+Venetoclax (VA) and Bridging CD19CD22 CAR-T Therapy in Adult Patients With Newly Diagnosed High-Risk and Ph-negative (Ph-) B-ALL
Anticipated Study Start Date :
Oct 10, 2023
Anticipated Primary Completion Date :
Sep 10, 2024
Anticipated Study Completion Date :
Sep 10, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: CAR-T therapy

Therapeutic outcomes in adults with Ph- B-ALL have substantially improved in the last decade, with complete remission (CR) and long-term overall survival (OS) rates of around 90% and 40%-50%, respectively. The presence of measurable residual disease (MRD) is the strongest predictor of relapse in B-ALL. In this study, high risk Ph- B-ALL patients receive the induction chemotherapy with Azacitidine+Venetoclax. After induction chemotherapy with Azacitidine+Venetoclax (VA regime), each subject receives CD19CD22 CAR-T cells by intravenous infusion. The patients with MRD negative will undergo HSCT.

Drug: Azacitidine Injection
Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection
Other Names:
  • Azacitidine

    • Drug: Venetoclax
    Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral
    Other Names:
  • ABT-199

    • Drug: CD19CD22 CAR-T
    After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion
    Other Names:
  • GDC-0199

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complete Remission Rate [The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion]

      MRD Negative Remission Rate after CD19CD22 cell therapy

    Secondary Outcome Measures

    1. Complete Remission Rate of VA regime [The cycle of VA regime is day 21; Effect evaluation was day 7 after VA regime]

      Complete Remission Rate after VA regime

    2. Complete Molecular Remission Rate [The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion]

      Complete Molecular Remission Rate after CD19CD22 CAR-T cell therapy

    3. Overall survival (OS) [The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion]

      From the first infusion of CD19CD22 cells to death or the last visit

    4. Leukemia-free survival (LFS) [The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion]

      Up to 2 years after CD19CD22 CAR-T cells infusion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 Criteria:

    1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;

    2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;

    3. Pregnant (or lactating) women;

    4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);

    5. Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus

    6. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;

    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 or interfere with the results of study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The First Affiliated Hospital of Soochow University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The First Affiliated Hospital of Soochow University
    ClinicalTrials.gov Identifier:
    NCT06078306
    Other Study ID Numbers:
    • High Risk B-ALL
    First Posted:
    Oct 11, 2023
    Last Update Posted:
    Oct 17, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Azacitidine
    Venetoclax

    Study Results

    No Results Posted as of Oct 17, 2023