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Recruiting

NCT Number: NCT07137312

Ex Vivo Expansion (ACT-X)

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Keith Knutson, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw

Procedure

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.

Other names: Blood sample collection, Biospecimen collection, Specimen collection

Apheresis

Procedure

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 outcomes

  1. Immune effector networks

    Time frame: Baseline; 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.

  2. Dendritic cell signaling programs

    Time frame: Baseline; 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.

  3. Cytokine capture methods

    Time frame: Baseline; 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Center Clinical Trials

CONTACT

507-293-6386

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

MC240903 Ex Vivo Expansion of Tumor Antigen-Specific T Cells for Adoptive T Cell Therapy

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 22, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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