Anti-ALPP CAR-T Cells Immunotherapy for Advanced Solid Tumors

Launched by XINQIAO HOSPITAL OF CHONGQING · Nov 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called anti-ALPP CAR-T cell therapy for patients with advanced solid tumors that test positive for a specific marker called ALPP. The main goal is to see how safe and effective this treatment is. The trial is currently recruiting participants, specifically women aged between 25 and 66 who are expected to live for at least three more months and have no other treatment options available.

To participate, patients need to have certain health conditions, such as good blood cell counts and liver function. They should not have autoimmune diseases or other serious health issues that could interfere with the study. If eligible, participants will receive this innovative therapy and will be closely monitored for any side effects and how well the treatment is working. Overall, this trial represents a hopeful step forward in finding new ways to treat difficult-to-treat solid tumors.

Gender

FEMALE

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