Growing immune cells outside the body to study neoantigen cancer vaccines (ACT-X)
MC240903 Ex Vivo Expansion of Tumor Antigen-Specific T Cells for Adoptive T Cell Therapy
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07137312 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Keith Knutson, PhD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.