Pharmacokinetic Study of Therapeutic Plasma Exchange

NCT07756242 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IRB26-0307
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immune-related Adverse Event

Keywords

Therapeutic plasma exchange; TPE; Immune Checkpoint Inhibitors; Immune-related Adverse Events; Pharmacokinetics; Pembrolizumab; Nivolumab; Ipilimumab

Outcome Measures

Primary Outcomes (1)

• Change in circulating ICI concentration during and after TPE/PLEX

  This will be measured by ICI concentration before and after TPE/PLEX sessions when paired samples are available, Percent change in ICI concentration from pre- to post-TPE/PLEX, and ICI concentration-time profiles across available PK sampling time points

  Baseline to Day 90

Secondary Outcomes (1)

• Assess the feasibility of conducting a small PK-focused Phase 1 study of TPE/PLEX in patients with severe irAEs.

  Baseline to Day 90

Study Arms (1)

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.

Device: Spectra Optia Apheresis System

Interventions

Spectra Optia Apheresis System DEVICE

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

Therapeutic plasma exchange (TPE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subject population consists of people who have a planned or is currently undergoing a TPE procedure at the University of Chicago Medicine.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected at 5 different timepoints.

Study Officials

• Pankti Reid

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pankti Reid

CONTACT

(773) 702-1234; pankti.reid@bsd.uchicago.edu

Mohamed Ali

CONTACT

Mohamed.Ali@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)