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.
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
Drug | Synonyms | Arms |
---|
Retroviral vector-transduced autologous T cells to express anti-ALPP CARs | | CART 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
Name | Type | Description | Interventions |
---|
CART treatment | Experimental | 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 | - 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