Exercise as an Immune Adjuvant for Allogeneic Cell Therapies

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 24, 2018

Primary Completion Date

December 30, 2028

Study Completion Date

December 30, 2028

Conditions
LeukemiaHematopoetic Stem Cell TransplantationDonor Lymphocyte InfusionCAR T-Cell TherapyLymphomaCell Therapy
Interventions
BEHAVIORAL

Exercise

After an initial maximal graded exercise test to determine maximal oxygen uptake and peak cycling power, healthy participants will undergo a 20-minute graded exercise test at intensities corresponding to 50, 60, 70 and 80% VO2max (5-minutes per stage)

DRUG

Isoproterenol

To determine if pharmacological activation of beta-adrenergic receptors evokes an immune respponse akin to exercise, healthy participants will receive an intravenous infusion of isoproterenol (50ng/kg/min)

DRUG

Placebo

Healthy participants will consume the placebo 2-3h prior to completing a 20-minute graded exercise test at intensities ranging from 50-80-% of the maximal oxygen uptake

DRUG

Bisoprolol Fumarate Tablet 10 mg

Healthy participants will consume a 10mg Bisoprolol Fumerate tablet 2-3h prior to completing a 20-minute graded exercise test at intensities ranging from 50-80-% of the maximal oxygen uptake

DRUG

Nadolol (1 x 80 mg) Tablets (Invamed, Inc)

Healthy participants will consume a 80mg Nadolol tablet 2-3h prior to completing a 20-minute graded exercise test at intensities ranging from 50-80-% of the maximal oxygen uptake

DRUG

Carvedilol 50 mg

Healthy participants will consume a 50mg Carvedilol tablet 2-3h prior to completing a 20-minute graded exercise test at intensities ranging from 50-80-% of the maximal oxygen uptake

DRUG

Roflumilast 500 Mcg Oral Tablet

Healthy participants will consume a 500mcg Roflumilast tablet and a 10mg Bisoprolol tablet 2-3h prior to completing a 20-minute graded exercise test at intensities ranging from 50-80-% of the maximal oxygen uptake

Trial Locations (1)

85719

RECRUITING

The University of Arizona, Tucson

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of Arizona

OTHER

NCT06643221 - Exercise as an Immune Adjuvant for Allogeneic Cell Therapies | Biotech Hunter | Biotech Hunter