Recruiting

Neoantigen Vaccine

Sponsor:

Mayo Clinic

Code:

NCT07137312

Conditions

Solid Tumor

Healthy

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Blood Draw

Apheresis

Study Details

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, the study team will collect a research specimen from participants to study their immune cells' reactions to the neoantigen vaccine. This research will help researchers learn more about how these vaccines might work to protect or treat against cancer.

Conditions

Solid Tumor

Healthy

Malignant Solid Neoplasm

Study ID

NCT07137312

Start date

Dec 16, 2025

Status verified date

Jun, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

24 participants

Anticipated

Interventions and Outcome Measures

Arms

Blood Draw Group

Participants who elect to provide specimen via standard blood draw. Some participants may provide a specimen via blood draw one time (the "blood draw group") and then elect to provide a second optional specimen via apheresis (the "apheresis group") or vice versa. Thus, which specimen collection group a given participant is in may change based on patient and provider preference for a given visit.

Apheresis Group

Participants who elect to provide specimen via apheresis. Apheresis is a procedure where blood is drawn from the body, specific components like plasma, platelets, and/or white blood cells are separated out, and the rest of the blood is returned. Some participants may provide a specimen via apheresis one time (the "apheresis group") and then elect to provide a second optional specimen via a standard blood draw (the "blood draw group") or vice versa. Thus, which specimen collection group a given participant is in may change based on patient and provider preference for a given visit.

Interventions

Blood Draw

Participants have a standard blood draw or apheresis on study. Some participants may provide a specimen via apheresis one time (the "blood draw group") and then elect to provide a second optional specimen via a standard blood draw (the "apheresis draw group") or vice versa.

Apheresis

Participants have a standard blood draw or apheresis on study. Apheresis is a procedure where blood is drawn from your body, specific components like plasma, platelets, and/or white blood cells are separated out, and the rest of the blood is returned. Some participants may provide a specimen via apheresis one time (the "apheresis group") and then elect to provide a second optional specimen via a standard blood draw (the "blood draw group") or vice versa.

Primary outcome measure

  • Immune effector networks [ Time Frame: Baseline; up to 3 years ]
  • Dendritic cell signaling programs [ Time Frame: Baseline; up to 3 years ]
  • Cytokine capture methods [ Time Frame: Baseline; up to 3 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials

507-293-6386

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Keith Knutson, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-09.