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

Primary Purpose

B Acute Lymphoblastic Leukemia, Ph-Negative ALL, High Risk Acute Lymphoblastic Leukemia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Azacitidine Injection
Venetoclax
CD19CD22 CAR-T
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Acute Lymphoblastic Leukemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age≥18 and ≤65 years old Newly diagnosed and high risk B-ALL according to the 2022 WHO classification The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-; Anticipated survival time more than 12 weeks; Those who voluntarily participated in this trial and provided informed consent. Exclusion Criteria: History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Pregnant (or lactating) women; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; Other uncontrolled diseases that were not suitable for this trial; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CAR-T therapy

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Complete Remission Rate
    MRD Negative Remission Rate after CD19CD22 cell therapy

    Secondary Outcome Measures

    Complete Remission Rate of VA regime
    Complete Remission Rate after VA regime
    Complete Molecular Remission Rate
    Complete Molecular Remission Rate after CD19CD22 CAR-T cell therapy
    Overall survival (OS)
    From the first infusion of CD19CD22 cells to death or the last visit
    Leukemia-free survival (LFS)
    Up to 2 years after CD19CD22 CAR-T cells infusion

    Full Information

    First Posted
    September 11, 2023
    Last Updated
    October 15, 2023
    Sponsor
    The First Affiliated Hospital of Soochow University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06078306
    Brief Title
    CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 10, 2023 (Anticipated)
    Primary Completion Date
    September 10, 2024 (Anticipated)
    Study Completion Date
    September 10, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital of Soochow University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    B Acute Lymphoblastic Leukemia, Ph-Negative ALL, High Risk Acute Lymphoblastic Leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CAR-T therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Azacitidine Injection
    Other Intervention Name(s)
    Azacitidine
    Intervention Description
    Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection
    Intervention Type
    Drug
    Intervention Name(s)
    Venetoclax
    Other Intervention Name(s)
    ABT-199
    Intervention Description
    Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral
    Intervention Type
    Drug
    Intervention Name(s)
    CD19CD22 CAR-T
    Other Intervention Name(s)
    GDC-0199
    Intervention Description
    After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion
    Primary Outcome Measure Information:
    Title
    Complete Remission Rate
    Description
    MRD Negative Remission Rate after CD19CD22 cell therapy
    Time Frame
    The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
    Secondary Outcome Measure Information:
    Title
    Complete Remission Rate of VA regime
    Description
    Complete Remission Rate after VA regime
    Time Frame
    The cycle of VA regime is day 21; Effect evaluation was day 7 after VA regime
    Title
    Complete Molecular Remission Rate
    Description
    Complete Molecular Remission Rate after CD19CD22 CAR-T cell therapy
    Time Frame
    The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
    Title
    Overall survival (OS)
    Description
    From the first infusion of CD19CD22 cells to death or the last visit
    Time Frame
    The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion
    Title
    Leukemia-free survival (LFS)
    Description
    Up to 2 years after CD19CD22 CAR-T cells infusion
    Time Frame
    The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age≥18 and ≤65 years old Newly diagnosed and high risk B-ALL according to the 2022 WHO classification The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-; Anticipated survival time more than 12 weeks; Those who voluntarily participated in this trial and provided informed consent. Exclusion Criteria: History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Pregnant (or lactating) women; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; Other uncontrolled diseases that were not suitable for this trial; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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