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RecruitingNCT07137312Updated Jun 9, 2026

Ex Vivo Expansion (ACT-X)

An observational study in Solid Tumor, Healthy and Malignant Solid Neoplasm, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Solid Tumor
  • Healthy
  • Malignant Solid Neoplasm
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Male and female participants who have/had cancer or are healthy individuals who would like to contribute to cancer research efforts.

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
24 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Procedure: Blood Draw · Procedure: Apheresis

  • 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.

    Procedure: Blood Draw · Procedure: Apheresis

Interventions

  • ProcedureBlood 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.

    Also known as: Blood sample collection, Biospecimen collection, Specimen collection

  • ProcedureApheresis

    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.

06

What researchers measure

Primary outcomes

  1. Immune effector networks

    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.

    Time frame: Baseline; up to 3 years

  2. Dendritic cell signaling programs

    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.

    Time frame: Baseline; up to 3 years

  3. Cytokine capture methods

    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.

    Time frame: Baseline; up to 3 years

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Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224, United States
    Recruiting
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07137312
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Aug 22, 2025
Start date
Dec 16, 2025
Primary completion
Oct 31, 2028 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Jun 9, 2026

Study contacts

Clinical Trials Referral Office
Contact
mayocliniccancerstudies@mayo.edu
855-776-0015
Cancer Center Clinical Trials
Contact
507-293-6386
Keith Knutson, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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