RECRUITING

Exercise as an Immune Adjuvant for Allogeneic Cell Therapies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to improve the treatment of blood cancer by using exercise to collect healthier immune cells from donors. Allogeneic adoptive cell therapy is a treatment where immune cells from a healthy donor are given to a cancer patient, usually to help prevent or treat cancer relapse after a stem cell transplant. These donor cells can either be directly infused into the patient or grown in a lab to create more specialized immune cells that target and kill cancer. While this therapy has been helpful for many patients, there is a need to make it more effective for a larger group and reduce side effects like graft-versus-host disease (GvHD), where the donor's immune cells attack the patient's healthy tissue. This Early Phase 1 trial will test whether exercise can help produce better immune cells from donors. The investigators will recruit healthy participants for three study groups: 1. Exercise Group: Participants will complete a 20-minute cycling exercise session. The investigators will collect blood samples before, during, and after exercise to study the number and quality of immune cells. The investigators will also use the collected cells to create immune therapies and test their ability to kill cancer cells in the lab and control cancer growth in mice. 2. Exercise and Beta Blocker Group: In this group, participants will complete up to five cycling sessions, with at least a week between each session. Before each session, participants will take either a placebo or a drug (beta blocker) that blocks stress hormones like adrenaline. The investigators will collect blood samples before and during exercise to see how blocking these hormones changes the effect of exercise on immune cells. 3. Isoproterenol Group: Participants in this group will receive a 20-minute infusion of isoproterenol, a drug that mimics the effects of adrenaline. The investigators will collect blood samples before, during, and after the infusion to see if the drug causes similar immune changes to those caused by exercise. Participants can join one, two, or all three groups. This research will help understand whether exercise can improve immune cell therapies for treating blood cancer and reduce the risk of GvHD, making these treatments safer and more effective.

Official Title

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

Quick Facts

Study Start:2018-01-24
Study Completion:2028-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06643221

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be between 21 and 55 years of age.
  2. * Be classified as 'low-risk' for graded exercise/stress testing according to ACSM-AHA criteria.
  3. * Have no contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast as per FDA guidelines.
  1. * Currently use tobacco products or have quit within the last 6 months.
  2. * Have a body mass index (BMI) greater than 34 kg/m² or waist circumference exceeding 102 cm for men and 88 cm for women.
  3. * Use any medications known to affect the immune system or regularly take ibuprofen/aspirin, antidepressants, or medications that alter blood pressure or cardiovascular function.
  4. * Use of hormone replacement therapy.
  5. * Are pregnant or breastfeeding.
  6. * Have chronic or debilitating arthritis or have been bedridden in the past three months.
  7. * Experienced a common illness (e.g., colds) within the past 6 weeks.
  8. * Have central or peripheral nervous disorders, a history of stroke, or major affective disorder.
  9. * Are infected with HIV or hepatitis or have any autoimmune disease.
  10. * Have known cardiovascular disease or contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast.
  11. * Use any prescription medications or have an allergy to beta-blockers.
  12. * Have a resting heart rate of less than 50 beats per minute.
  13. * Suffer from asthma, emphysema, bronchitis, kidney disease, pheochromocytoma, diabetes, overactive thyroid, or a history of severe anaphylactic reactions.
  14. * Are scheduled for surgery.
  15. * Family History: Myocardial infarction, coronary revascularization, or sudden death before 55 years of age in a father or male first-degree relative, or before 65 years of age in a mother or female first-degree relative.
  16. * Hypertension: Systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg.
  17. * Dyslipidemia: Total serum cholesterol exceeding 200 mg/dl.
  18. * Pre-diabetes: Fasting blood glucose levels between 100 mg/dl and 126 mg/dl.

Contacts and Locations

Study Locations (Sites)

The University of Arizona
Tucson, Arizona, 85719
United States

Collaborators and Investigators

Sponsor: University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-24
Study Completion Date2028-12-30

Study Record Updates

Study Start Date2018-01-24
Study Completion Date2028-12-30

Terms related to this study

Keywords Provided by Researchers

  • exercise
  • cell therapy
  • beta-blockers
  • immune function
  • phosphodiesterase inhibitor
  • CAR T-cells
  • NK-cells
  • cytokine-induced killer cells
  • cytokine-induced memory-like NK-cells
  • monoclonal antibodies
  • leukemia
  • lymphoma
  • donor lymphocyte infusion
  • gamma-delta T-cells

Additional Relevant MeSH Terms

  • Leukemia
  • Hematopoetic Stem Cell Transplantation
  • Donor Lymphocyte Infusion
  • CAR T-Cell Therapy
  • Lymphoma
  • Cell Therapy