Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
NCT ID: NCT04195347
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
42 participants
INTERVENTIONAL
2020-09-04
2029-01-31
Brief Summary
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Primary Objectives
To assess the safety of CM4620 administration in children and young adults with asparaginase associated pancreatitis (AAP).
To profile dose-limiting toxicities and responses of the patients treated in the dose-finding phase.
To estimate the efficacy of CM4620 to prevent pseudocyst or necrotizing pancreatitis in children with AAP.
Secondary Objectives
To determine the effect of CM4620 on the incidence of severe pancreatitis
To determine the effect of CM4620 on the incidence of Systemic Inflammatory Response Syndrome (SIRS).
Detailed Description
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An initial 9 patients (cohort 1) will be enrolled and will receive dose level 1 and monitored for toxicity. If the therapy is well tolerated, 6 patients (cohort 2) will be treated at dose level 2. Subsequent enrollment of 9 patients (cohort 3) will be at either dose level 1 or 2 based on tolerability. The keyboard design will be used to determine the dosing for cohorts 2 and 3. Additional patients will be enrolled at the recommended phase II dose (RP2D) until a total of 24 patients have been treated at that dose, including any treated during the dose-finding phase.
CM4620 will be given days 1-4 as an IV infusion beginning within 36 hours of the onset of acute pancreatitis associated abdominal pain and within 8 hours of enrollment. For patients with prior abdominal pain or in those unable to communicate the location/characteristic of their pain, a change in the characteristic of the pain or new enzyme elevation/imaging findings after previously normal studies will determine the timing of onset of pancreatitis.
Patients will be followed for about 4 months after treatment.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CM4620 Treatment
Phase I:
Cohort 1 patients receive CM4620 IV at dose level 1 on days 1-4. Cohort 2 patients receive CM4620 IV at dose level 2 on days 1-4. Cohort 3 patients receive CM4620 IV at either dose level 1 or 2 on days 1-4
Phase II:
Patients will receive CM4620 IV on days 1-4 at the recommended Phase II dose (RP2D) as determined in Phase I.
CM4620
IV
Interventions
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CM4620
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
21 Years
ALL
No
Sponsors
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CalciMedica, Inc.
INDUSTRY
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Seth E. Karol, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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Novant Health Presbyterian Hemby Children's Hospital
Charlotte, North Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Jessica Bell, MD
Role: primary
Role: backup
Seth E. Karol, MD
Role: primary
Related Links
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St. Jude Children's Research Hospital
ClinicalTrials Open at St. Jude
Other Identifiers
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NCI-2019-08205
Identifier Type: REGISTRY
Identifier Source: secondary_id
CRSPA
Identifier Type: -
Identifier Source: org_study_id