Exercise and Immune Cell Collection for Blood Cancers
This study is exploring how exercise can help collect healthier immune cells from donors for people with blood cancers like leukemia and lymphoma. These donor cells are used in treatments like allogeneic cell therapy (where immune cells from a healthy donor are given to a cancer patient) to prevent or treat cancer relapse after a stem cell transplant. Researchers are testing if exercise, or certain medications like isoproterenol, Bisoprolol Fumarate, or Nadolol, can improve the quality of these immune cells. The study aims to make these therapies more effective and reduce side effects like graft-versus-host disease (GvHD), where donor cells attack the patient's healthy tissue. They will measure immune cell changes and how well these cells might fight cancer. This study is for healthy volunteers aged 21 to 55.
- Study design
- This interventional study plans to enroll 200 healthy participants. It compares the effects of exercise, isoproterenol, Bisoprolol Fumarate, and Nadolol on immune cells.
- What's involved
- You would undergo an initial maximal exercise test, then participate in 20-minute graded exercise tests. You might also receive an intravenous infusion of isoproterenol or take Bisoprolol Fumarate or Nadolol tablets before exercise tests.
- Compensation
- Not stated in the trial record.
- Follow-up
- Immune cell changes and cell fighting ability will be measured immediately after interventions. Tumor burden and tumor-free survival will be measured for up to 120 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Exercise as an Immune Adjuvant for Allogeneic Cell Therapies
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Immune Cell Enumeration and Phenotypingimmediately after the intervention
Whole blood samples will be analyzed for complete blood counts and to quantify lymphocyte and monocyte subtypes using flow cytometry and a comprehensive immunophenotyping panel. This panel is designed to identify major immune cell populations, as well as markers related to differentiation, exhaustion, migration, activation, and inhibition. Specific cell types expressing a surface protein, or combinations of surface proteins, will be reported as the percentage of cells positive for expression and/or by mean fluorescent intensity (MFI). For descriptive purposes, the cell counts of all major lymphocyte and monocyte subtypes will be expressed as cells per microliter (cells/µL) of whole blood. Additionally, isolated peripheral blood mononuclear cells (PBMCs) and expanded cell products will be quantified and phenotyped in a similar manner.
- Cytolysis in vitroimmediately after the intervention
We will assess whether lymphocytes collected during or after exercise, as well as cell products manufactured from these lymphocytes, are more effective at killing hematologic cancer target cells. Using in vitro assays, such as flow cytometry and bioluminescence-based assays, we will compare the cytolytic activity of both the collected lymphocytes and the manufactured cell products to those obtained under resting conditions. Results will be measured as the time required to achieve 10%, 20%, 30%, 40%, and 50% cytolysis, or as the percentage of target cells killed at specific time points (e.g., 4, 8, 24, and 48 hours). We will also evaluate the impact of combination therapies, such as monoclonal antibodies targeting the tumor model, as appropriate.
- Tumor Burden and Tumor Free Survivalup to 120-days
Tumor burden will be evaluated in immunocompromised mice engrafted with human tumors by measuring the size, number, and progression of tumors using imaging techniques such as bioluminescence, MRI, or CT scans, along with physical measurements where applicable. Overall tumor burden will be assessed through metrics like peak tumor size and photon intensity in bioluminescence imaging. Tumor-free survival will be defined as the time from treatment until either the recurrence of detectable tumors or the last follow-up without tumor recurrence. Data will be reported as overall tumor reduction (e.g., percentage decrease in tumor size or number), peak tumor burden, and photon intensity, as well as the duration of tumor-free survival in days. Additional analyses will explore the effects of treatment on delaying tumor progression and improving overall survival.
- Clinical xGvHD Scoreup to 120-days
The development of xGvHD (xenogeneic graft-versus-host disease) will be assessed using a clinical scoring system with a possible aggregate score ranging from 0 to 10. Animals will be monitored regularly, and a total score of 5 or higher on two consecutive assessment days will indicate the presence of moderate xGvHD. This scoring system allows for the systematic evaluation of disease severity and progression in response to treatment.
- Survivalup to 120 days
Survival will be monitored as a critical endpoint in this study. Death will be recorded when any of the following criteria are met: (1) the animal experiences greater than 20% weight loss compared to its baseline weight at two consecutive weigh-ins, indicating significant deterioration in health; or (2) the animal exhibits signs of severe morbidity, characterized by an xGvHD score exceeding 7. These criteria ensure that any adverse effects related to treatment or disease progression are accurately captured, allowing for a comprehensive assessment of the survival outcomes in the context of xGvHD.