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Blood filtering may tame severe immunotherapy side effects

NCT ID NCT07756242

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The University of Chicago

    Chicago, Illinois, 60637, United States

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