Acute PancreatitisPhase 1/2NCT04195347
Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
A Phase 1/2 study testing CM4620 in people with Acute Pancreatitis, run by St. Jude Children's Research Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- CM4620
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Sep 2020to Jan 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Novant Health Presbyterian Hemby Children's Hospital
Charlotte, North Carolina, 28204
Jessica Bell, MD
704-384-1900, jbell@novanthealth.org
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45220
Robin Morris, MD, 513-636-2047, Robin.morris@cchmc.org
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Seth E. Karol, MD, 888-226-4343, referralinfo@stjude.org
Seth E. Karol, MD
About this study
Official title: CRSPA: Phase I/II Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
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
Read more
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).
Read the detailed description
This is an open label safety and efficacy evaluation with comparison of toxicity to a historical control population (TOTXVI). There will be 3 cohorts of patients enrolled, and the dose for each cohort will be determined based on the toxicities experienced in the ongoing and prior cohorts.
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
- Acute Pancreatitis
- Being tested
- CM4620
- Keywords
- Acute Pancreatitis, Asparaginase, Asparaginase Associated Pancreatitis, Acute Lymphoblastic Leukemia, Acute Lymphoblastic Lymphoma, CM4620, Children, SIRS, Systemic Inflammatory Response, Young Adults
- Medical subject headings
- Pancreatitis, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM4620Drug
Also called CM4620-IE
IV
| Study group | Role | What they receive |
|---|---|---|
| CM4620 Treatment | Experimental | 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. Receives: Drug: CM4620 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of CTCAE grade 3-5 events
Drug safety measuring the number of CTCAE grade 3-5 events
Measured: Within 28 days of receiving the medication
Responses to CM4620
We will evaluate the rate of pancreatic necrosis or pseudocyst formation using radiographic imaging
Measured: 28-35 days after study entry.
Secondary outcomes (4)
Effect of CM4620 measured by levels of pancreatic enzymes
Pancreatitis measured by levels of pancreatic enzymes
Measured: 72 hours after study entry
Effect of CM4620: Necrosis
Necrosis measured by levels of pancreatic enzymes
Measured: 28-35 days from study entry
Effect of CM4620: Pseudocyst
Pseudocyst measured by levels of pancreatic enzymes
Measured: 28-35 days from study entry
Effect of CM4620: Incidence of SIRS
Presence or absence of systemic inflammatory response syndrome
Measured: 48-72 hours after study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start4 Sep 2020
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CalciMedica, Inc.
- Responsible party
- Sponsor
- Investigators
- Seth E. Karol, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195347
- Sponsor's protocol ID
- CRSPA
- Other IDs
- NCI-2019-08205
- Status last verified
- Jun 2026
- First submitted
- 25 Nov 2019
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.