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Pilot Study of Infliximab for Checkpoint Inhibitor Associated Diabetes Mellitus

This study, called the CERT Project, is looking at whether a medication called infliximab can help people who have developed diabetes (high blood sugar) after receiving a type of cancer treatment called a checkpoint inhibitor. The goal is to see if infliximab can reverse the need for insulin in these patients. You might be able to join if you are 18 or older, have new diabetes or worsening blood sugar control requiring insulin after checkpoint inhibitor treatment, and your last dose of checkpoint inhibitor was within the last 12 months. The study will measure if infliximab is safe and how well it works to help people stop taking insulin. The current status of this study is unclear, and it plans to enroll 14 participants.

Study design
This is an interventional pilot study, meaning participants will receive a specific treatment. It plans to enroll 14 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07257068

Checkpoint Inhibitor Associated Diabetes Mellitus: Early Recognition and Treatment (CERT) Project: A Pilot Study

Not Yet Recruiting
NAAges 18+InterventionalTreatment
M.D. Anderson Cancer Center
~14 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Infliximab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs).
Measured over Through study completion; an average of 1 year.

Conditions

Checkpoint Inhibitor
Pilot Study
Diabetes Melletus

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Checkpoint Inhibitor Associated Diabetes MellitusC Peptide

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Priyanka C Iyer, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Priyanka C Iyer, MD
[email protected]
832) 291-6069
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Participants already on insulin for pre-existing type 1 or type 2 diabetes.
Participants with undetectable c-peptide levels i.e. \<0.2 with blood glucose of 145 mg/dl or higher.
For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Participants with a h/o active TB or latent TB will be excluded.
Participants with known history of any NYHA class heart failure or ejection fraction \<50% will be excluded.
Participants requiring supraphysiological doses of steroids i.e. prednisone \>10mg of equivalent at the time of study entry, will be excluded
Participants who have ICI hepatitis and myocarditis will be excluded
Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities ≥ Grade 2) with the exception of alopecia.
Participants who are receiving any other investigational agents for CIADM.
History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to Infliximab or other agents used in study.
Required: any concomitant drugs used as defined in section 5.7 will be excluded.
Participants with uncontrolled intercurrent illness: active infection/ sepsis
Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant and breastfeeding women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with infliximab. Breastfeeding should be discontinued if the mother is treated with infliximab. These potential risks may also apply to other agents used in this study

What this trial measures

  • Safety and adverse events (AEs).Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0