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Understanding Immune Cell Responses to Neoantigen Vaccines (ACT-X)

This observational study, called ACT-X, aims to understand how your body's immune cells react to a new type of vaccine called a neoantigen vaccine. This vaccine is designed to help your immune system recognize and fight cancer. Researchers will collect a blood sample from you, either through a standard blood draw or apheresis (a procedure where blood is drawn, specific components are separated, and the rest is returned). They will then study your immune cells' reactions to the neoantigen vaccine. This research will help scientists learn more about how these vaccines might work to protect against or treat solid tumors. You may be eligible if you are 18 or older, have a current or past solid tumor, or are a healthy individual, and are willing to provide a blood sample.

Study design
This is an observational study with a planned enrollment of 24 participants. It is not specified if it is randomized or blinded.
What's involved
You would provide a research blood sample, either through a standard blood draw or apheresis, at baseline. Some participants may provide a second optional sample.
Compensation
Not stated in the trial record.
Follow-up
Immune responses will be measured at baseline and for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07137312

Ex Vivo Expansion (ACT-X)

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~24 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Blood DrawApheresis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Immune effector networks
Measured over Baseline; up to 3 years
+2 more outcomes measured

Conditions

Solid Tumor
Healthy
Malignant Solid Neoplasm

Explore related trials

Solid Neoplasm

NCT07137312

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Florida

    Jacksonville, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Keith Knutson, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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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

What this trial measures

  • Immune effector networksBaseline; up to 3 years

    Specimen samples obtained by blood draw and/or apheresis will be analyzed to identify immune effector networks that accelerate ex vivo expansion of antigen-specific memory precursor T cells. All tests will be two sided with a p\<0.05 being considered as statistically significant.

  • Dendritic cell signaling programsBaseline; up to 3 years

    Specimen samples obtained by blood draw and/or apheresis will be analyzed to define dendritic cell signaling programs that foster generation of polyfunctional, high avidity antigen-specific T cells capable of recognizing naturally processed tumor antigen. All tests will be two sided with a p\<0.05 being considered as statistically significant.

  • Cytokine capture methodsBaseline; up to 3 years

    Specimen samples obtained by blood draw and/or apheresis will be analyzed to identify cytokine capture methods for isolation of antigen-specific T cells. All tests will be two sided with a p\<0.05 being considered as statistically significant.