Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor (NCT06105021)
🩺 Plain-English Summary (8th-Grade Level)
This study is open to adult patients with solid tumors who have a KRAS G12V mutation. This mutation is often found in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) and other cancers. The study is for patients whose cancer has spread through the body and for whom previous treatments were not successful or treatment does not exist. Patients must also be positive for HLA-A\*11:01. The purpose of this study is to find the best dose of AFNT-211 that is safe and can shrink tumors in patients. AFNT-211 is an investigational therapy and this is the first time that AFNT-211 is being administered to patients. AFNT-211 is an autologous T cell product which means that it is made from a patient's own T cells. These cells are engineered and grown to recognize the KRAS G12V protein on the cell surface of cancer cells. AFNT-211 is infused into patients after a short course of lymphodepleting chemotherapy. Patients will frequently visit the study site. The doctors there will regularly check the size of the cancer and the patient's health. They will also take note of any unwanted effects. Patients may continue in this study for as long as they benefit from the treatment.
Who can join: Review the eligibility criteria below.
Location: USC Norris Comprehensive — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- USC Norris Comprehensive — Los Angeles, California
- University of California Los Angeles Department of Medicine — Los Angeles, California
- Yale New Haven Hospital — New Haven, Connecticut
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Providence Cancer Institute Franz Clinic — Portland, Oregon
- Sarah Cannon Research Institute — Nashville, Tennessee
- MD Anderson Cancer Center — Houston, Texas
- Fred Hutchinson Cancer Center — Seattle, Washington
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.