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

Ovarian Cancer Clinical Trial

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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04627740
• Other study ID #: TCRCureALPPCART
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2020
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing	TCRCure Biopharma Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	Objective response rate to ALPP-CART infusion	The number of patients experience objective response from anti-ALPP CAR-T cells treatment	Eight weeks
Secondary	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.	6 months
Secondary	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	6 months