Recruiting

Phase 1

Phase 2

CM4620Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT04195347

Conditions

Acute Pancreatitis

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

CM4620

Study Details

Brief summary:

This is a phase I/II clinical trial assessing the tolerability and efficacy of CM4620 in children and young adults with acute pancreatitis caused by asparaginase. The tolerability of CM4620 when given to patients receiving frontline chemotherapy will be determined. The effectiveness in reducing the severity of pancreatitis will be estimated.

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).

Conditions

Acute Pancreatitis

Study ID

NCT04195347

Start date

Sep 4, 2020

Status verified date

Jun, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

CM4620

Primary outcome measure

The number of CTCAE grade 3-5 events [ Time Frame: Within 28 days of receiving the medication ]
Responses to CM4620 [ Time Frame: 28-35 days after study entry. ]

Central Contacts and Locations

Central contacts

Seth E. Karol, MD

888-226-4343 referralinfo@stjude.org

Locations

Novant Health Presbyterian Hemby Children's Hospital

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

704-384-1900 jbell@novanthealth.org

Principal Investigator:

Jessica Bell, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Robin Morris, MD

513-636-2047 Robin.morris@cchmc.org

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Seth E. Karol, MD

888-226-4343 referralinfo@stjude.org

Principal Investigator:

Seth E. Karol, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

Acute Pancreatitis
Asparaginase
Asparaginase Associated Pancreatitis
Acute Lymphoblastic Leukemia
Acute Lymphoblastic Lymphoma
CM4620
Children
SIRS
Systemic Inflammatory Response
Young Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-06-03.