Blood filtering may tame severe immunotherapy side effects
NCT ID NCT07756242
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This study looks at whether a procedure called therapeutic plasma exchange—which filters the blood—can help remove immune checkpoint inhibitor drugs from the body in people who develop severe immune-related side effects from cancer treatment. The trial will measure how drug levels change during and after the procedure in about 15 adults with cancer who are receiving or recently received these immunotherapy drugs. The goal is to understand how plasma exchange affects drug levels, which could guide future management of these serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Therapeutic plasma exchange using the Spectra Optia Apheresis System
- What this could lead to
- If successful, this could help doctors better manage severe immune-related side effects from cancer immunotherapy by understanding how plasma exchange clears these drugs from the body.
- What could go wrong
- This is a small early-phase study with only 15 participants, so results may not apply broadly. Plasma exchange carries risks like bleeding, infection, or allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The subject population consists of people who have a planned or is currently undergoing a TPE procedure at the University of Chicago Medicine.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults ≥ 18 years of age * Diagnosis of any malignancy. * Receiving or recently received an immune checkpoint inhibitor, including anti-PD-1, anti-PD-L1, anti-CTLA-4, or combination ICI therapy. Eligible agents may include, but are not limited to, pembrolizumab, nivolumab, atezolizumab, durvalumab, avelumab, cemiplimab, dostarlimab, and ipilimumab. * Received an ICI within 12 weeks prior to planned enrollment, or within a timeframe considered appropriate by the PI for PK evaluation based on the specific ICI agent, dosing history, and assay feasibility. * Suspected or confirmed severe or clinically significant immune-related adverse event for which the treating clinical team considers TPE/PLEX clinically appropriate. * Planned to undergo or currently undergoing TPE/PLEX at the University of Chicago Medicine. * Approval from the patient's primary clinical service for study participation. * Able to provide written informed consent, or has a legally authorized representative able to provide consent if permitted by the IRB-approved consent process. * In the opinion of the treating team and study team, PK blood sample collection can be performed without delaying or interfering with clinically indicated care. Exclusion Criteria: * No prior exposure to an immune checkpoint inhibitor. * TPE/PLEX is being performed for an indication unrelated to a suspected or confirmed ICI-associated immune-related adverse event. * Inability to provide informed consent and no legally authorized representative is available, if applicable. * PK blood sample collection is not feasible without delaying, altering, or interfering with clinically indicated care. * Any condition that, in the opinion of the investigator or treating team, would make participation in the research procedures unsafe or inappropriate.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Chicago
Chicago, Illinois, 60637, United States
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