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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04627740
Recruitment Status : Not yet recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
TCRCure Biopharma Corporation
Information provided by (Responsible Party):
Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing

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

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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


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




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



Information from the National Library of Medicine

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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
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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