Ex Vivo Expansion (ACT-X)

Not yet recruiting

• Conditions: Solid Tumor; Healthy

• Registration Number: NCT07137312
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-15
• Study First Submitted QC: 2025-08-15
• Last Update Submitted: 2025-08-15
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Study Start: 2025-10-01
• Primary Completion: 2028-10
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune effector networks	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.
Dendritic cell signaling programs	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.
Cytokine capture methods	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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States