Immunotherapy using anti-ALPP CAR-T cells for advanced solid tumors
A Single-Arm, Single-Center, Open-Label Pilot Study of Anti-ALPP CART-cells in Patient With Alkaline Phosphatase, Placental (ALPP)-Positive Advanced Solid Tumor
This study is testing a new type of immune therapy using modified T cells to see if it can help people with advanced solid tumors that have a specific marker called ALPP.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Xinqiao Hospital of Chongqing Academic / other |
| Drugs / interventions | CAR-T, chimeric antigen receptor, CART |
| Locations | 1 site (ChongQing, Chongqing) |
| Trial ID | NCT04627740 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and effectiveness of anti-ALPP chimeric antigen receptor (CAR)-modified T cells in patients with ALPP-positive advanced solid tumors. The study will evaluate treatment-related adverse events and the objective response rate following the infusion of these modified T cells. Additionally, it will measure progression-free survival and the persistence of CAR-T cells in the bloodstream over a six-month period. The trial includes both Phase 1 and Phase 2 evaluations to gather comprehensive data on the treatment's impact.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with ALPP-positive advanced solid tumors who have no curative treatment options available.
Not a fit: Patients with autoimmune diseases or uncontrolled active diseases that could hinder participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with advanced solid tumors that express ALPP.
How similar studies have performed: While CAR-T cell therapies have shown success in hematological malignancies, this specific approach targeting ALPP in solid tumors is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
ChongQing, Chongqing
- Department of Oncology, Xinqiao Hospital — ChongQing, Chongqing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.