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Clinical trial Recruiting at 1 site Observational Ages 18 and up

Growing immune cells outside the body to study neoantigen cancer vaccines (ACT-X)

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

Run by Mayo Clinic · NCT07137312 · Data updated 2026-11-12

This project tests how immune cells from people with or without solid tumors react to a new neoantigen vaccine by collecting blood or apheresis samples.

More Solid Tumor trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment24 (estimated)
SponsorMayo Clinic
Academic / other
Drugs / interventionsprednisone
Locations1 site (Jacksonville, Florida)
StatusRecruiting
StartedDecember 16, 2025
Main results expectedOctober 31, 2028
Study endsOctober 31, 2028
Registry record updatedJune 9, 2026
Trial IDNCT07137312 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with a current or prior histologically confirmed solid malignancy, or healthy volunteers, who can give written consent, meet basic blood-count requirements, and are willing to undergo blood draws or apheresis.

Probably not a fit

Patients who are immunocompromised, have active hepatitis, HIV on antiretroviral therapy, recent major surgery, recent live vaccination, recent IV antibiotics, or active hematologic malignancy are excluded and unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects blood and apheresis samples from participants with current or past solid tumors and from healthy volunteers. Laboratory teams expand immune cells ex vivo and expose them to neoantigen vaccine components to measure cellular responses. Researchers will compare immune activation, cell types, and functional responses across participants to identify common immune signatures. The results are intended to inform neoantigen vaccine design rather than to provide direct treatment to participants.

Why it matters

Potential benefit: If successful, the findings could help researchers design neoantigen vaccines that better stimulate anti-tumor immune responses.

How similar studies have gone: Other early-phase neoantigen vaccine studies have produced promising immune responses, but ex vivo expansion assays like this are exploratory and have not yet been shown to improve patient outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • Mayo Clinic in Florida
    Jacksonville, Florida, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.