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
About this trial
This is an interventional treatment trial for Ovarian Cancer
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
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
NCT ID
NCT04627740
First Posted
November 5, 2020
Last Updated
November 11, 2020
Sponsor
Xinqiao Hospital of Chongqing
Collaborators
TCRCure Biopharma Ltd.
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
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