Pharmacokinetic Study of Therapeutic Plasma Exchange

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07756242
Status
Not Yet Recruiting

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Conditions

  • Immune-related Adverse Event

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spectra Optia Apheresis System — DEVICE
    Therapeutic plasma exchange (using the Spectra Optia Apheresis System) will be done according to standard of care.

Study Details

The purpose of this study is to characterize the pharmacokinetics of one or more ICIs during and after TPE/PLEX in patients with severe irAEs.

Key Dates

First listed
Aug 10, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
15 participants (estimated)

Arms

  • Arm: Therapeutic plasma exchange (TPE)
    Patients with severe immune-related adverse events (irAEs) from immune checkpoint inhibitors (ICIs) who will received therapeutic plasma exchange (TPE; performed using FDA-cleared apheresis devices (Spectra Optia Apheresis System)) as part of their standard-of-care.

Primary Outcome Measure

Change in circulating ICI concentration during and after TPE/PLEX [ Time Frame: Baseline to Day 90 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637
Pankti Reid, MD
[email protected]
Mohamed Ali, MD
[email protected]
Pankti Reid, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Chicago· Chicago, IL