To find out if taking a drug called infliximab (the "study drug") is safe and effective in reversing insulin dependence in CIADM.
New onset diabetes≥ 200 mg/dl and/or A1c ≥6.5 OR
Worsening glycemic control: requiring insulin per clinician assessment (fasting glucose or average glucose on CGM>20% and /or A1c >0.5% from prior to ICI use ) AND /OR
If Presenting with DKA/HHS: include if within 6 weeks of presentation AND
Must have detectable random c-peptide level 0.2 - 1 ng/mL with blood glucose of 145 mg/dl
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.
Single group
Infliximab
Other interventionGiven by IV
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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This trial is not recruiting at the moment. You can still explore other options:
