NCT06105021Active, not recruitingPhase 1/2
Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor
Source: ClinicalTrials.gov · Last updated 30 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 9 Oct 2023
- Start date
- 6 Mar 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Affini-T Therapeutics, Inc.
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer, Sarcoma
- NCT number
- NCT06105021
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 100
- From 6 Mar 2024 to the primary completion date, Dec 2025
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Any prior gene therapy utilizing an integrating vector
- Previous allogeneic stem cell transplantation or prior organ transplantation
- Surgery or catheter-based interventions
- Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with lymphodepleting chemotherapy (LDC) or AFNT-211 product
- Diagnosis of another malignancy within 2 years prior to screening.
Other illness
- History of treated primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease
- Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
- Uncontrolled active bacterial, viral, fungal, or mycobacterial infection
- Uncontrolled significant intercurrent or recent illness
- Seropositive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb)
- Seropositive for hepatitis C antibody.
- Known human immunodeficiency virus (HIV) infection
Other
- Primary brain tumor
- Pregnant or lactating subjects
Who the study is looking for
- Confirmed KRAS G12V mutational status and HLA-A\*11:01 allele
- Histologically confirmed advanced or metastatic, unresectable solid tumor
- Progressed on or intolerant of at least one prior line of standard systemic therapy for the current malignancy.
- Measurable disease per RECIST v1.1.
- ECOG performance status 0-1
- Adequate organ and bone marrow function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of California Los Angeles Department of Medicine Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| USC Norris Comprehensive Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Wisconsin Carbone Cancer Center Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Providence Cancer Institute Franz Clinic Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.