search
Back to results

Anti-ALPP CAR-T Cells Immunotherapy for Ovarian and Endometrial Cancer

Primary Purpose

Ovarian Cancer, Endometrial Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Retroviral vector-transduced autologous T cells to express anti-ALPP CARs
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Expected to survive more than 3 months
  • PS 0-2
  • Immunohistochemistry was confirmed to be mesothelin positive ALPP (higher than 50%)
  • Patients with no curative regimen to receive
  • WBC>3.5×1e+9/L,Hb>90g/L,PLT>75×1e+9/L
  • HBV DNA copy number less than 100/ml
  • ALT≤5ULN, AST≤5ULN, TB≤1.5ULN, ALB≥35g/L
  • Understand this test and have signed informed consent

Exclusion Criteria:

  • Autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial
  • Decompensated liver cirrhosis, liver function Child-pugh C grade
  • Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous
  • Long-term use of immunosuppressive agents after organ transplantation
  • Screening indicated that the target cell transfection rate was less than 30%
  • Invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization
  • Subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization
  • Pregnant or lactating subjects
  • In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration
  • Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CART treatment

    Arm Description

    Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered

    Outcomes

    Primary Outcome Measures

    Number of patients suffering treatment-related AE
    To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.

    Secondary Outcome Measures

    Objective response rate to ALPP-CART infusion
    The number of patients experience objective response from anti-ALPP CAR-T cells treatment
    Progression-free survival to ALPP-CART infusion
    To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with mesothelin-positive advanced ovarian carcinoma.
    Number of peripheral CAR-T after infusion
    The number of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion

    Full Information

    First Posted
    November 5, 2020
    Last Updated
    November 11, 2020
    Sponsor
    Xinqiao Hospital of Chongqing
    Collaborators
    TCRCure Biopharma Ltd.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04627740
    Brief Title
    Anti-ALPP CAR-T Cells Immunotherapy for Ovarian and Endometrial Cancer
    Official Title
    A Single-Arm, Single-Center, Open-Label Pilot Study of Anti-ALPP CART-cells in Patient With Alkaline Phosphatase, Placental (ALPP)-Positive Metastatic Ovarian and Endometrial Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xinqiao Hospital of Chongqing
    Collaborators
    TCRCure Biopharma Ltd.

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to evaluate the safety and efficacy of anti-ALPP chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with ALPP-positive metastatic ovarian and endometrial cancer.
    Detailed Description
    Primary Objectives: To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells. Secondary Objectives: The number of patients experience objective response from anti-ALPP CAR-T cells treatment To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with ALPP-positive patients. The number and percent of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer, Endometrial Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, 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
    CART treatment
    Arm Type
    Experimental
    Arm Description
    Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered
    Intervention Type
    Drug
    Intervention Name(s)
    Retroviral vector-transduced autologous T cells to express anti-ALPP CARs
    Intervention Description
    Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered
    Primary Outcome Measure Information:
    Title
    Number of patients suffering treatment-related AE
    Description
    To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Objective response rate to ALPP-CART infusion
    Description
    The number of patients experience objective response from anti-ALPP CAR-T cells treatment
    Time Frame
    Eight weeks
    Title
    Progression-free survival to ALPP-CART infusion
    Description
    To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with mesothelin-positive advanced ovarian carcinoma.
    Time Frame
    6 months
    Title
    Number of peripheral CAR-T after infusion
    Description
    The number of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Expected to survive more than 3 months PS 0-2 Immunohistochemistry was confirmed to be mesothelin positive ALPP (higher than 50%) Patients with no curative regimen to receive WBC>3.5×1e+9/L,Hb>90g/L,PLT>75×1e+9/L HBV DNA copy number less than 100/ml ALT≤5ULN, AST≤5ULN, TB≤1.5ULN, ALB≥35g/L Understand this test and have signed informed consent Exclusion Criteria: Autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial Decompensated liver cirrhosis, liver function Child-pugh C grade Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous Long-term use of immunosuppressive agents after organ transplantation Screening indicated that the target cell transfection rate was less than 30% Invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization Subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization Pregnant or lactating subjects In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Anti-ALPP CAR-T Cells Immunotherapy for Ovarian and Endometrial Cancer

    We'll reach out to this number within 24 hrs