Immune-related Adverse EventNCT07756242
Pharmacokinetic Study of Therapeutic Plasma Exchange
An observational study of Immune-related Adverse Event, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune-related Adverse Event
- What is being tested?
- Spectra Optia Apheresis System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Feb 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Pharmacokinetic Study of Therapeutic Plasma Exchange for Severe Immune-Related Adverse Events From Immune Checkpoint Inhibitors
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.
Read the detailed description
Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy across multiple tumor types; however, their mechanism of action-releasing immune inhibition-inevitably predisposes patients to immune-related adverse events (irAEs). These toxicities occur in up to 74% of patients treated with PD-(L)1 inhibitors and in more than 90% of those receiving combination therapy, with grade 3-5 events in 14-55% of cases depending on regimen and tumor type. Immune-related adverse events caused by ICIs often present with a spectrum of clinical manifestations that closely resemble primary autoimmune diseases affecting multiple organ systems, including the skin, gastrointestinal tract, liver, lung, and nervous system.
Therapeutic plasma exchange is an established therapeutic procedure in selected immune-mediated diseases where rapid removal of circulating pathogenic material is clinically relevant (13). In these settings, TPE/PLEX can remove circulating antibodies, immune complexes, complement-related factors, inflammatory mediators, and therapeutic monoclonal antibodies. These precedents support the biologic rationale for considering TPE/PLEX in selected severe irAEs when treating clinicians believe that removal of circulating ICI and/or soluble immune mediators may be clinically appropriate. Immune-related adverse events are an acceptable indication for TPE/PLEX, and the procedure may be considered based on individual patient circumstances and treating-team judgment. The purpose of this small, single-arm, open-label Phase 1 pharmacokinetic study is to characterize ICI concentrations during and after TPE in patients with severe irAEs.
Timed PK blood samples will be collected during and after TPE/PLEX according to the study PK sampling plan. Clinically relevant information will be collected from participant's medical record throughout the study.
- Conditions
- Immune-related Adverse Event
- Being tested
- Spectra Optia Apheresis System
- Keywords
- Therapeutic plasma exchange, TPE, Immune Checkpoint Inhibitors, Immune-related Adverse Events, Pharmacokinetics, Pembrolizumab, Nivolumab, Ipilimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectra Optia Apheresis SystemDevice
Therapeutic plasma exchange (using the Spectra Optia Apheresis System) will be done according to standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Spectra Optia Apheresis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
This will be measured by the Proportion of eligible patients successfully identified and approached, approached patients who consent to study participation, enrolled patients who undergo at least one TPE/PLEX session, enrolled patients with at least one evaluable PK sample, enrolled patients with paired pre-/post-TPE/PLEX PK samples
Measured: Baseline to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Why it stopped: IRB Withdrew Study Due to Study Design Change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune-related Adverse EventStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pankti Reid, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756242
- Sponsor's protocol ID
- IRB26-0307
- Status last verified
- Sep 2026
- First submitted
- 12 May 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Pharmacokinetic Study of Therapeutic Plasma Exchange for Severe Immune-Related Adverse Events From Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT07756242
- Acronym / sponsor ID
- IRB26-0307
- Conditions
- Immune-related Adverse Event
- Keywords
- Therapeutic plasma exchange, TPE, Immune Checkpoint Inhibitors, Immune-related Adverse Events, Pharmacokinetics, Pembrolizumab, Nivolumab, Ipilimumab
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: IRB Withdrew Study Due to Study Design Change
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy across multiple tumor types; however, their mechanism of action-releasing immune inhibition-inevitably predisposes patients to immune-related adverse events (irAEs). These toxicities occur in up to 74% of patients treated with PD-(L)1 inhibitors and in more than 90% of those receiving combination therapy, with grade 3-5 events in 14-55% of cases depending on regimen and tumor type. Immune-related adverse events caused by ICIs often present with a spectrum of clinical manifestations that closely resemble primary autoimmune diseases affecting multiple organ systems, including the skin, gastrointestinal tract, liver, lung, and nervous system.
Therapeutic plasma exchange is an established therapeutic procedure in selected immune-mediated diseases where rapid removal of circulating pathogenic material is clinically relevant (13). In these settings, TPE/PLEX can remove circulating antibodies, immune complexes, complement-related factors, inflammatory mediators, and therapeutic monoclonal antibodies. These precedents support the biologic rationale for considering TPE/PLEX in selected severe irAEs when treating clinicians believe that removal of circulating ICI and/or soluble immune mediators may be clinically appropriate. Immune-related adverse events are an acceptable indication for TPE/PLEX, and the procedure may be considered based on individual patient circumstances and treating-team judgment. The purpose of this small, single-arm, open-label Phase 1 pharmacokinetic study is to characterize ICI concentrations during and after TPE in patients with severe irAEs.
Timed PK blood samples will be collected during and after TPE/PLEX according to the study PK sampling plan. Clinically relevant information will be collected from participant's medical record throughout the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic plasma exchange (TPE) | – | Device: Spectra Optia Apheresis SystemPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectra Optia Apheresis SystemTherapeutic plasma exchange (using the Spectra Optia Apheresis System) will be done according to standard of care. | Device | Therapeutic plasma exchange (TPE) |
Primary outcome
Change in circulating ICI concentration during and after TPE/PLEX
Time frame: Baseline to Day 90
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
1 secondary outcome
Assess the feasibility of conducting a small PK-focused Phase 1 study of TPE/PLEX in patients with severe irAEs.
Time frame: Baseline to Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pankti Reid principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune-related Adverse Event, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in circulating ICI concentration during and after TPE/PLEX (time frame: Baseline to Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.