Clinical Trials /

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

NCT04627740

Description:

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.

Related Conditions:
  • Endometrial Carcinoma
  • Ovarian Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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.

Clinical Trial IDs

  • ORG STUDY ID: TCRCureALPPCART
  • NCT ID: NCT04627740

Conditions

  • Ovarian Cancer
  • Endometrial Cancer

Interventions

DrugSynonymsArms
Retroviral vector-transduced autologous T cells to express anti-ALPP CARsCART treatment

Purpose

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
    

Trial Arms

NameTypeDescriptionInterventions
CART treatmentExperimentalCyclophosphamide 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
  • Retroviral vector-transduced autologous T cells to express anti-ALPP CARs

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
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients suffering treatment-related AE
Time Frame:1 year
Safety Issue:
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.

Secondary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Xinqiao Hospital of Chongqing

Last Updated

November 13, 2020