Actively Recruiting

Early Phase 1
Age: 21Years - 55Years
All Genders
Healthy Volunteers
ID06643221

Exercise-induced Adrenergic Receptor Signaling as an Immune Adjuvant for Allogeneic Cell Therapies

Led by University of Arizona · Updated on 2026-06-05

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Arizona

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring ways to improve blood cancer treatment by using exercise to collect healthier immune cells from donors. This trial focuses on allogeneic adoptive cell therapy, where immune cells from healthy donors are given to cancer patients to prevent or treat relapse after stem cell transplant. The study aims to enhance the therapy's effectiveness and reduce side effects like graft-versus-host disease (GvHD), where donor cells attack the patient's healthy tissues. The trial includes three groups: one where participants complete a 20-minute cycling exercise and provide blood samples before, during, and after; another where participants take either a placebo or beta blocker drugs before exercise sessions to study hormone effects on immune cells; and a third where participants receive a 20-minute infusion of isoproterenol, a drug that mimics adrenaline, with blood samples collected similarly. Participants can join one, two, or all groups. Participants will undergo various assessments including exercise tests, blood sampling, and monitoring by cardiologists. Blood samples will be analyzed to count and study immune cells, test their ability to kill cancer cells in the lab, and observe effects on tumor growth in mice. The study also measures clinical outcomes like tumor burden, survival, and GvHD scores over up to 120 days. The goal is to understand how exercise and related treatments can improve immune cell therapies for blood cancers.

CONDITIONS

Brief Title

Exercise as an Immune Adjuvant for Allogeneic Cell Therapies

Who Can Participate

Age: 21Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 21 and 55 years of age.
  • Be classified as 'low-risk' for graded exercise/stress testing according to ACSM-AHA criteria.
  • Have no contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast as per FDA guidelines.
Not Eligible

You will not qualify if you...

  • Currently use tobacco products or have quit within the last 6 months.
  • Have a body mass index (BMI) greater than 34 kg/m2 or waist circumference exceeding 102 cm for men and 88 cm for women.
  • Use medications known to affect the immune system or regularly take ibuprofen/aspirin, antidepressants, or medications affecting blood pressure or heart function.
  • Use hormone replacement therapy.
  • Are pregnant or breastfeeding.
  • Have chronic or debilitating arthritis or have been bedridden in the past three months.
  • Experienced a common illness within the past 6 weeks.
  • Have central or peripheral nervous disorders, history of stroke, or major affective disorder.
  • Are infected with HIV or hepatitis or have any autoimmune disease.
  • Have known cardiovascular disease or contraindications for certain study drugs.
  • Use any prescription medications or have an allergy to beta-blockers.
  • Have a resting heart rate less than 50 beats per minute.
  • Suffer from asthma, emphysema, bronchitis, kidney disease, pheochromocytoma, diabetes, overactive thyroid, or history of severe allergic reactions.
  • Are scheduled for surgery.
  • Have more than one cardiovascular risk factor such as family history of early heart disease, hypertension, high cholesterol, or pre-diabetes, unless cleared by a cardiologist.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Exercise Cohort Testing

Duration - Approximately 3 weeks

Participants complete an initial maximal graded exercise test to determine maximal oxygen uptake and peak cycling power, followed by two separate visits involving 20-minute graded exercise sessions at varying intensities with blood sample collection before, during, and after exercise.

1 visit for graded exercise test and 2 exercise visits with blood draws (all in-person)

Exercise + Beta Blocker Cohort Testing

Duration - 6 to 10 weeks

Participants complete a graded exercise test followed by five exercise trial visits where they ingest specific drugs or placebo prior to 20-minute graded exercise sessions with blood samples collected pre-drug, post-drug pre-exercise, during exercise, and post-exercise recovery.

6 visits total (all in-person)

Isoproterenol Infusion Cohort Testing

Duration - 1 day

Participants undergo screening and then receive a 20-minute intravenous isoproterenol infusion with multiple blood samples collected before, during, and after infusion alongside continuous monitoring.

1 infusion visit (in-person)

Trial Site Locations

Total: 1 location

1

The University of Arizona

Tucson, Arizona, United States, 85719

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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Published Research Related To This Trial

Acute exercise mobilizes NKT-like cells with a cytotoxic transcriptomic profile but does not augment the potency of cytokine-induced killer (CIK) cells.

Tiffany M Zúñiga, Forrest L Baker, Kyle A Smith...

https://pubmed.ncbi.nlm.nih.gov/36189306

Human lymphocytes mobilized with exercise have an anti-tumor transcriptomic profile and exert enhanced graft-versus-leukemia effects in xenogeneic mice.

Helena Batatinha, Douglass M Diak, Grace M Niemiro...

https://pubmed.ncbi.nlm.nih.gov/37077913

Exercise-induced β2-adrenergic Receptor Activation Enhances the Antileukemic Activity of Expanded γδ T-Cells via DNAM-1 Upregulation and PVR/Nectin-2 Recognition.

Forrest L Baker, Kyle A Smith, Preetesh L Mylabathula...

https://pubmed.ncbi.nlm.nih.gov/38592213

Exercise-mobilized lymphocytes enhance the function of cytokine-induced memory-like NK cells against myeloid leukemia.

Helena Batatinha, Angella M Valenzuela, Dimitrios Filioglou...

https://pubmed.ncbi.nlm.nih.gov/41538301