Status:
RECRUITING
Ex Vivo Expansion (ACT-X)
Lead Sponsor:
Mayo Clinic
Conditions:
Solid Tumor
Healthy
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to understand how the body's immune cells respond to a new type of vaccine (neoantigen vaccine) designed to help the immune system recognize and fight cancer. To do this, ...
Eligibility Criteria
Inclusion
- Histologically confirmed current or previous solid malignancy or healthy individuals
- Willing to provide mandatory research blood draw or apheresis per protocol
- Provide written informed consent
- The following laboratory values obtained ≤ 28 days prior to registration
- Hemoglobin ≥10.0 g/dl
- Absolute neutrophil count (ANC) ≥1500/mm\^3
- Platelet count ≥100,000/mm\^3
Exclusion
- Any of the following prior therapies:
- IV antibiotic ≤2 weeks prior to apheresis
- Major Surgery ≤4 weeks prior to registration
- Received a live vaccine ≤30 days prior to registration
- Active hematologic malignancies ≤ 3 years prior to registration
- Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
- History of active tuberculosis (TB), human immunodeficiency virus (HIV), active hepatitis B (e.g., HBsAg reactive), and/or active hepatitis C infection \[e.g., Hepatitis C Virus (HCV) ribonucleic acid (RNA) qualitative is detected)
- Known history of active autoimmune disease that has required systemic treatment in the ≤14 days (i.e., with the use of disease-modifying agents, corticosteroids \>10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to registration.
- NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Pregnancy
Key Trial Info
Start Date :
December 16 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07137312
Start Date
December 16 2025
End Date
October 1 2028
Last Update
December 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224