Using engineered T cells to treat advanced solid tumors with a specific mutation
Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor
This study is testing a new treatment that uses specially modified T cells to help adults with advanced solid tumors that have a specific mutation called KRAS G12V.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Affini-T Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine |
| Locations | 11 sites (Los Angeles, California and 10 other locations) |
| Trial ID | NCT06105021 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on adult patients with advanced or metastatic solid tumors that have a KRAS G12V mutation and are positive for HLA-A*11:01. The investigational therapy, AFNT-211, involves engineering a patient's own T cells to target and attack cancer cells expressing the KRAS G12V protein. Patients will undergo a short course of lymphodepleting chemotherapy before receiving the T cell infusion. The study aims to determine the safety, tolerability, and optimal dosing of AFNT-211 while also evaluating its preliminary anti-tumor activity.
Who should consider this trial
Good fit: Ideal candidates include adults with unresectable solid tumors harboring a KRAS G12V mutation and who have previously failed standard treatments.
Not a fit: Patients with solid tumors that do not have the KRAS G12V mutation or those who have had prior gene therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors that currently have limited or no effective therapies.
How similar studies have performed: While the approach of using engineered T cells is gaining traction, this specific application targeting KRAS G12V is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Confirmed KRAS G12V mutational status and HLA-A\*11:01 allele 2. Histologically confirmed advanced or metastatic, unresectable solid tumor 3. Progressed on or intolerant of at least one prior line of standard systemic therapy for the current malignancy. 4. Measurable disease per RECIST v1.1. 5. ECOG performance status 0-1 6. Adequate organ and bone marrow function Key Exclusion Criteria: 1. Any systemic cytotoxic chemotherapy, investigational agents, or any anti-tumor drug from a previous treatment regimen or clinical study (including small molecules and I/O compounds) within 5 half-lives or 14 days of Screening, whichever is shorter. 2. Any prior gene therapy utilizing an integrating vector 3. Previous allogeneic stem cell transplantation or prior organ transplantation 4. History of treated primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease 5. Primary brain tumor 6. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. 7. Uncontrolled active bacterial, viral, fungal, or mycobacterial infection 8. Pregnant or lactating subjects 9. Surgery or catheter-based interventions 10. Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with lymphodepleting chemotherapy (LDC) or AFNT-211 product 11. Uncontrolled significant intercurrent or recent illness 12. Diagnosis of another malignancy within 2 years prior to screening. 13. Seropositive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) 14. Seropositive for hepatitis C antibody. 15. Known human immunodeficiency virus (HIV) infection
Where this trial is running
Los Angeles, California and 10 other locations
- USC Norris Comprehensive — Los Angeles, California, United States (Recruiting)
- University of California Los Angeles Department of Medicine — Los Angeles, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Providence Cancer Institute Franz Clinic — Portland, Oregon, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Soumit Basu
- Email: AFNT211info@affinittx.com
- Phone: 617-380-3109
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.