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.
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
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of patients suffering treatment-related AE
Secondary Outcome
Objective response rate to ALPP-CART infusion
Condition
Ovarian Cancer
Intervention
Retroviral vector-transduced autologous T cells to express anti-ALPP CARs
Study Arms / Comparison Groups
CART treatment
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
December 1, 2020
Completion Date
December 31, 2023
Primary Completion Date
December 31, 2022
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
Gender
Female
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Administrative Informations
NCT ID
NCT04627740
Organization ID
TCRCureALPPCART
Responsible Party
Principal Investigator
Study Sponsor
Xinqiao Hospital of Chongqing
Collaborators
TCRCure Biopharma Ltd.
Study Sponsor
, ,
Verification Date
November 2020