Phase 1 Study of attIL12-T Cell Therapy Combined with Cyclophosphamide for Advanced Soft Tissue and Bone Sarcomas

What this Trial Is About

Researchers are evaluating a new T-cell membrane-anchored tumor targeted IL12 attIL12-T cell therapy combined with cyclophosphamide in patients with advanced or metastatic soft tissue or bone sarcomas. This phase 1 trial aims to find the best dose for treatment and to understand the safety, tolerability, and early signs of disease control, especially in patients with recurrent unresectable osteosarcoma. The study also explores immune responses and tumor cell changes related to the therapy. Participants will receive attIL12-T cell therapy combined with cyclophosphamide administered intravenously. The study includes two parts Part A focuses on finding the safe and recommended dose, starting with the lowest dose, while Part B involves treating patients with osteosarcoma at the recommended dose found in Part A. Treatment schedules depend on the participants group and study phase. During the trial, participants will undergo tumor biopsies when possible and provide blood samples to assess immune changes. Researchers will monitor adverse events to evaluate safety for about one year. The main measurement is the incidence of side effects, and disease control will also be assessed over four months. Participants must meet specific health and organ function criteria and will be closely followed up throughout the study period.

A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma