Phase 1 Study to Evaluate Safety and Dose of ZI-MA4-1 TCR-NK Cell Therapy in Adults With Inoperable or Metastatic MAGE-A4 Positive Solid Tumors Including Ovarian, Lung, Sarcoma, and Head and Neck Cancer

What this Trial Is About

Researchers are evaluating an investigational treatment called ZI-MA4-1, an allogeneic cell therapy, for patients with several types of advanced or metastatic solid cancers including ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma, and head and neck cancer. These cancers currently have limited treatment options and a poor outlook. This Phase 1 study aims to assess the safety and tolerability of ZI-MA4-1 and to determine the best dose for future studies. Participants receive ZI-MA4-1 through intravenous infusion three times per treatment cycle, with each participant planned to receive at least one and up to two treatment cycles. Before each cycle, patients undergo lymphodepletion using chemotherapy drugs fludarabine and cyclophosphamide to prepare the body for the cell therapy. The study has two parts Part A focuses on finding the maximum tolerated dose through dose escalation, and Part B expands evaluation of the recommended dose across different cancer types. During the study, participants will be monitored regularly for safety and treatment effects over up to five years. Researchers will assess responses using imaging and other tests to measure tumor changes, disease control, and how the therapy moves through the body. Participants must meet specific health and disease criteria to join, and the study includes careful follow-up to watch for any side effects or longer-term impacts of the treatment.

A Study to Test the Safety, Tolerability and Effect of ZI-MA4-1 for Patients With Locally Advanced or Metastatic Solid Malignancies