Ex Vivo Expansion (ACT-X)

Mayo Clinic

Status: Enrolling

Conditions: Solid Tumor; Healthy; Malignant Solid Neoplasm

Treatments: Procedure: Apheresis; Procedure: Blood Draw

Study type: Observational

Funder types: Other

Identifiers

NCT07137312

NCI-2025-06055 (Other Identifier)

MC240903

24-011832 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

Blood Draw Group

Description:

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.

Treatment:

Procedure: Blood Draw

Procedure: Apheresis

Apheresis Group

Description:

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.

Treatment:

Procedure: Blood Draw

Procedure: Apheresis