Ex Vivo Expansion (ACT-X)

Official title

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

Overview

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.

Interventions

• Procedure Blood Draw
  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.
• Procedure Apheresis
  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 outcome measures

• Immune effector networks [Time frame: Baseline; up to 3 years]
• Dendritic cell signaling programs [Time frame: Baseline; up to 3 years]
• Cytokine capture methods [Time frame: Baseline; up to 3 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-only

Study locations

United States · 1 center

• Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT07137312 · MC240903 · 24-011832

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗