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Recruiting NCT07137312

Ex Vivo Expansion (ACT-X)

Trial Parameters

Condition Solid Tumor
Sponsor Mayo Clinic
Study Type OBSERVATIONAL
Phase N/A
Enrollment 24
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-16
Completion 2028-10
Interventions
Blood DrawApheresis

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.

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) qualita

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