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

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinqiao Hospital of Chongqing
• Collaborator: TCRCure Biopharma Corporation

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