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CM4620 for Pancreatitis Caused by Asparaginase

This study is testing a drug called CM4620 to see if it can reduce the severity of acute pancreatitis (inflammation of the pancreas) in children and young adults. This type of pancreatitis is caused by a chemotherapy medicine called asparaginase. Researchers want to find out if CM4620 is safe to use with other cancer treatments and how well it works to prevent serious problems like pseudocysts (fluid collections) or necrotizing pancreatitis (tissue death). You might be able to join if you are 21 years old or younger, have acute pancreatitis with specific blood test results, and have received asparaginase within the last 49 days. The study will look at how many serious side effects occur and how patients respond to CM4620.

Study design
This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It will involve up to 42 participants, with different groups receiving varying doses of CM4620 to find the safest and most effective amount.
What's involved
You would receive CM4620 as an IV infusion for four days, starting soon after your pancreatitis symptoms begin. You will be followed for about four months after your treatment.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for about four months after receiving treatment with CM4620.

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

NCT04195347

Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase

Recruiting
PHASE1Up to 21InterventionalTreatment
St. Jude Children's Research Hospital
~42 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:CM4620

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of CTCAE grade 3-5 events
Measured over Within 28 days of receiving the medication
+1 more outcome measured

Conditions

Acute Pancreatitis

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Where it's being run

3 sites across 3 states
North Carolina1
Ohio1
Tennessee1

Study leadership

  • Seth E. Karol, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Seth E. Karol, MD
[email protected]
888-226-4343
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Acute pancreatitis with elevation of amylase OR lipase ≥ 3x the upper limit of normal AND at least 1 of: abdominal pain consistent with acute pancreatitis OR imaging findings consistent with acute pancreatitis.
Receipt of any form of asparaginase within the prior 49 days.
Patient with acute lymphoblastic leukemia/ lymphoma age \< 22 years receiving therapy with curative intent.

Exclusion

Prior episode of pancreatitis.
QTc at baseline \> 450 msec.
Creatinine \> 3x the upper limit of normal for age or total bilirubin \>3x the upper limit for normal for age without evidence of leukemic infiltrate or hemolysis.
Receipt of another investigational agent within the prior 7 days.
History of allergy to eggs or known hypersensitivity to any component of CM4620.
Positive pregnancy test or breastfeeding. Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment. Males and females of childbearing potential must agree to use effective contraception for at least twelve months following the completion of therapy.
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

What this trial measures

  • The number of CTCAE grade 3-5 eventsWithin 28 days of receiving the medication

    Drug safety measuring the number of CTCAE grade 3-5 events

  • Responses to CM462028-35 days after study entry.

    We will evaluate the rate of pancreatic necrosis or pseudocyst formation using radiographic imaging