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Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor
NCT06105021 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG AFNT-211
Study Locations (10)
California
- USC Norris Comprehensive — Los Angeles
- University of California Los Angeles Department of Medicine — Los Angeles
New York
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York
- Memorial Sloan Kettering Cancer Center — New York
Connecticut
- Yale New Haven Hospital — New Haven
Oregon
- Providence Cancer Institute Franz Clinic — Portland
Tennessee
- Sarah Cannon Research Institute — Nashville
Texas
- MD Anderson Cancer Center — Houston
Washington
- Fred Hutchinson Cancer Center — Seattle
Wisconsin
- University of Wisconsin Carbone Cancer Center — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-03-06 |
| Est. Completion | 2029-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06105021
The ClinicalTrials.gov registry entry for NCT06105021 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Affini-T Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention — of which AFNT-211 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06105021 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, New York, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06105021 about?
NCT06105021 is a clinical study titled "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 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 ...
What is the current status of trial NCT06105021?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2024-03-06. Estimated completion is 2029-12.
What conditions does trial NCT06105021 study?
This clinical trial studies the following conditions: Colorectal Cancer, Solid Tumor, Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, KRAS G12V. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06105021?
The interventions under investigation include: AFNT-211 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06105021?
This trial is sponsored by Affini-T Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06105021 being conducted?
This trial has 10 study locations across California, Connecticut, New York, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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