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NCT06643221 · ClinicalTrials.gov registry record · Early Phase 1
Exercise as an Immune Adjuvant for Allogeneic Cell Therapies
A Early Phase 1 study of Lymphoma and Leukemia, sponsored by University of Arizona.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06643221: Recruiting Early Phase 1 study of Lymphoma and Leukemia, sponsored by University of Arizona.
NCT06643221 is a Early Phase 1 study of Lymphoma and Leukemia that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 100 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06643221, a Early Phase 1 study of Lymphoma and Leukemia, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
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 t
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- BEHAVIORAL Exercise
- DRUG Isoproterenol
- DRUG Bisoprolol Fumarate Tablet 10 mg
- DRUG Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
Study Locations (1)
Arizona
- The University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-01-24 |
| Est. Completion | 2028-12-30 |
| Phase | Early Phase 1 |
What NCT06643221 shows while recruiting
NCT06643221 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (79% lower).
The record links to 6 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT06643221 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT06643221 about?
NCT06643221 is a clinical study titled "Exercise as an Immune Adjuvant for Allogeneic Cell Therapies". 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 ste...
What is the current status of trial NCT06643221?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 100 participants. The study started on 2018-01-24. Estimated completion is 2028-12-30.
What conditions does trial NCT06643221 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia, CAR T-Cell Therapy, Cell Therapy, Hematopoetic Stem Cell Transplantation.
What interventions are being tested in trial NCT06643221?
The interventions under investigation include: Placebo (DRUG), Exercise (BEHAVIORAL), Isoproterenol (DRUG), Bisoprolol Fumarate Tablet 10 mg (DRUG), Nadolol (1 x 80 mg) Tablets (Invamed, Inc) (DRUG).
Who is sponsoring clinical trial NCT06643221?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06643221 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06643221's enrollment target sits among peer trials
100 81st of 299 higher than 213 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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