Study to Assess Safety of Single Dose Antibody-Armored Dendritic Cell Injection in Adults With Solid Tumors

What this Trial Is About

Researchers are conducting a single-arm, open-label study to evaluate the safety and tolerability of an antibody-armored dendritic cell injection in patients with solid tumors. This phase 1 trial focuses on patients with various types of solid cancers who have undergone surgery and standard chemotherapy. The study aims to determine the maximum tolerated dose and monitor adverse events over an extended period. Participants will receive a single administration of armored dendritic cells through multiple subcutaneous injections. The study is non-randomized and open-label, meaning all participants receive the same investigational treatment without placebo comparison. The dosing and safety will be assessed from day 0 up to 5 months, with additional monitoring of immune responses and tumor markers. Throughout the study, participants will be closely monitored with evaluations including laboratory tests, immune response assessments, and safety observations up to 24 months. Researchers will measure the concentration of tumor markers, T-cell responses, and adverse events to evaluate the treatments impact and safety profile. Participants must meet specific health and organ function criteria and will be followed for up to two years to track outcomes and side effects.

An Antibody-armored Dendritic Cell in Patients With Solid Tumors