Actively Recruiting
Phase I Study of Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors in Participants With Metastatic Solid Tumors With KRAS G12V Mutations
Led by Fred Hutchinson Cancer Center · Updated on 2025-12-19
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
A
Affini-T Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new treatment using a patient's own immune cells, called T cells, which are changed in the lab to better recognize and attack cancer cells with a specific mutation called KRAS G12V. This Phase I trial focuses on patients with metastatic solid tumors that have spread from the original site. The goal is to find the best dose and understand side effects of these modified T cells. Participants will first undergo a procedure called leukapheresis to collect T cells from their blood. Before receiving the modified T cells, patients get chemotherapy to prepare their body, either with cyclophosphamide and fludarabine or bendamustine. The modified T cells (FH-A11KRASG12V-TCR) are then given through an IV infusion on day 0. Some patients may receive a second infusion between 28 days and one year later. Before and during the study, patients will have scans like CT, PET, or MRI and tissue biopsies to monitor their disease and response. During the study, patients will be followed closely with imaging tests, blood samples, heart function scans, and biopsies at set times. Follow-up visits occur on days 56, 112, 168, 224, 280, and 365 after treatment, with long-term monitoring for up to 15 years. Researchers will track side effects, determine the best dose, and evaluate how well the treatment controls the cancer over time.
CONDITIONS
Brief Title
Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Solid Tumor Cancers With KRAS G12V Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of metastatic solid tumor confirmed by tissue pathology
- HLA-A*11:01 confirmed by clinical laboratory
- Documented KRAS G12V mutation in tumor or plasma by PCR or NGS
- Measurable disease by RECIST 1.1 criteria with at least one target lesion
- Willingness to undergo tumor biopsies if safe and feasible
- At least 2 weeks or five half-lives since last systemic cancer treatment
- Progressed on or intolerant to at least one prior therapy including targeted treatments
- Use of effective contraception before, during, and 4 months after last T-cell infusion
- Age 18 years or older
- Able to understand and provide written informed consent
- ECOG performance status of 1 or less
- No uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Renal function with creatinine clearance ≥ 50 ml/min
- Liver function with total bilirubin < 2.0 mg/dL (exceptions for Gilbert syndrome)
- AST and ALT less than 5 times upper limit of normal
- Cardiac function with LVEF ≥ 35% for participants 60 years or older
- Absolute neutrophil count ≥ 1000 cells/mm³
- Albumin ≥ 3 g/dL
You will not qualify if you...
- Prior solid organ transplant or allogeneic stem cell transplant (exceptions for kidney transplant with conditions)
- Pregnancy, breastfeeding, or expecting to conceive/father children during trial and 4 months after
- Active autoimmune disease requiring immunosuppressive therapy (some exceptions possible)
- Corticosteroid therapy above 0.5 mg/kg prednisone equivalent (some steroid forms permitted)
- Use of other investigational anti-cancer agents
- Active uncontrolled infection (HIV controlled with therapy and other viral infections controlled are allowed)
- Uncontrolled or concurrent illness that limits compliance or safety
- Untreated or uncontrolled brain metastases (small stable treated brain metastases allowed)
- Ongoing treatment for prior serious immune-related adverse events (some exceptions)
- Allergic reactions to any study treatment components
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Includes echocardiography (ECHO) or multigated acquisition scan (MUGA) and assessments for eligibility.
Duration - 6 days
Participants undergo leukapheresis followed by lymphodepletion chemotherapy before receiving the study treatment.
Visits on days -6, -5, and -4 for cyclophosphamide and fludarabine or days -4 and -3 for bendamustine chemotherapy; leukapheresis occurs prior to chemotherapy.
Duration - Up to 1 year
Participants receive an infusion of the investigational T-cell therapy and may receive an additional infusion between 28 days to 1 year later.
Initial infusion on day 0 and possible additional infusion between 28 days and 1 year after the first infusion.
Duration - Up to 15 years
Participants are monitored with imaging and biopsies after treatment to assess safety and disease status, continuing long-term for up to 15 years.
Visits on days 56, 112, 168, 224, 280, and 365, then long-term follow-up visits thereafter.
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
F
Fred Hutch Intake
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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