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

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ClinicalTrials.gov Identifier: NCT04627740
Recruitment Status : Not yet recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
TCRCure Biopharma Ltd.
Information provided by (Responsible Party):
Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Endometrial Cancer Drug: Retroviral vector-transduced autologous T cells to express anti-ALPP CARs Phase 1 Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CART treatment
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
 Drug: Retroviral vector-transduced autologous T cells to express anti-ALPP CARs
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients suffering treatment-related AE [ Time Frame: 1 year ]
    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 :
  1. Objective response rate to ALPP-CART infusion [ Time Frame: Eight weeks ]
    The number of patients experience objective response from anti-ALPP CAR-T cells treatment

  2. Progression-free survival to ALPP-CART infusion [ Time Frame: 6 months ]
    To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with mesothelin-positive advanced ovarian carcinoma.

  3. Number of peripheral CAR-T after infusion [ Time Frame: 6 months ]
    The number of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Qingzhu Jia, M.D., Secretary, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT04627740    
Other Study ID Numbers: TCRCureALPPCART
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
 Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases