Using exercise to enhance immune cell therapy for blood cancer
Exercise-induced Adrenergic Receptor Signaling as an Immune Adjuvant for Allogeneic Cell Therapies
This study tests if a short cycling exercise can improve immune cells from healthy donors to help treat blood cancers like leukemia and lymphoma more effectively.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Drugs / interventions | blinatumomab, CAR T, cart, chimeric antigen receptor, immunotherapy |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT06643221 on ClinicalTrials.gov |
What this trial studies
This study investigates the potential of exercise to improve the quality of immune cells collected from healthy donors for use in treating blood cancers such as leukemia and lymphoma. Participants will engage in a 20-minute cycling exercise session to see if this can enhance the effectiveness of allogeneic adoptive cell therapies, which involve infusing donor immune cells into cancer patients. The trial aims to reduce side effects like graft-versus-host disease while improving treatment outcomes. It will involve healthy volunteers who meet specific cardiovascular health criteria to ensure safety during the exercise sessions.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals who are asymptomatic and have no more than one risk factor for cardiovascular disease.
Not a fit: Patients with significant cardiovascular risks or those who do not meet the health screening criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer immune cell therapies for patients with blood cancers.
How similar studies have performed: While exercise has been shown to improve outcomes in cancer survivors, this specific approach to enhance immune cell therapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Procedures are in place for protecting against or minimizing the risks to the healthy volunteers recruited for this study. Physical risk to volunteers and matched related donors will be protected through health screening to determine study eligibility, and medical monitoring with an established test termination criterion during the exercise and isoproterenol infusion trials. To protect against the remote risk of an adverse cardiac event occurring during exercise and isoproterenol infusion, the study will only enroll volunteers who are considered "low risk" for maximal stress testing in accordance with the guidelines published by the American College of Sports Medicine (ACSM) and American Heart Association (AHA). Individuals who are considered "low risk" are men and women who are asymptomatic and have no more than one risk factor for cardiovascular disease (CVD). The risks to subjects are therefore extremely low. All infusions will take place in the Clinical and Translational Sciences Research Center (CATS) Infusion Suite, which is a designated University of Arizona campus facility for infusion trials and equipped with appropriate medical personnel and monitoring equipment (i.e. ECG). The graded exercise tests and isoproterenol infusions procedures will be performed under the direction of a licensed and board-certified cardiologist Inclusion Criteria: Participants must: * 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. Exclusion Criteria: Participants will be excluded if they: * 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 any medications known to affect the immune system or regularly take ibuprofen/aspirin, antidepressants, or medications that alter blood pressure or cardiovascular function. * Use of 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 (e.g., colds) within the past 6 weeks. * Have central or peripheral nervous disorders, a 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 the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast. * Use any prescription medications or have an allergy to beta-blockers. * Have a resting heart rate of less than 50 beats per minute. * Suffer from asthma, emphysema, bronchitis, kidney disease, pheochromocytoma, diabetes, overactive thyroid, or a history of severe anaphylactic reactions. * Are scheduled for surgery. Additionally, participants who meet the inclusion criteria but present with more than one of the following cardiovascular disease (CVD) risk factors will be excluded unless cleared by a cardiologist: * 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. * Hypertension: Systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg. * Dyslipidemia: Total serum cholesterol exceeding 200 mg/dl. * Pre-diabetes: Fasting blood glucose levels between 100 mg/dl and 126 mg/dl.
Where this trial is running
Tucson, Arizona
- The University of Arizona — Tucson, Arizona, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.