Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis

Launched by NOVEOME BIOTHERAPEUTICS, FORMERLY STEMNION · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ST266 for infants with a serious condition known as Necrotizing Enterocolitis (NEC). NEC can cause the intestines to become damaged and inflamed, and this study aims to find out if two different doses of ST266, given once a day through an IV, are safe for babies and if they can help improve their condition. The trial is currently looking for premature infants who weigh between 800 grams and 3,000 grams and have been diagnosed with at least stage IIA NEC, which means they have specific signs of the condition confirmed by medical imaging.

To participate, infants must be between 14 to 56 days old and have their parents' written consent. However, certain infants are not eligible, including those with severe medical conditions that make survival unlikely, major birth defects, or certain blood disorders. If selected for the study, participants will receive the treatment and be closely monitored for any side effects or reactions. This trial is an important step in understanding how ST266 might help improve the health of infants suffering from NEC.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Infants born from ≥26 weeks gestational age to 40 weeks gestational age; up to 40 weeks postmenstrual gestational age (gestational age plus chronological age in terms of weeks) with current weight at diagnosis of NEC between ≥800g and ≤3000g as a result of prematurity and/or IUGR. Parent(s)/legal medical representative(s) voluntarily provides written consent prior to study enrollment.
• • 2. Minimum Bell stage IIA NEC diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus.
• Exclusion Criteria:
• • 1. Infants with abdominal perforation at less than 10 days of life
• • 2. Not expected to survive ≥2 weeks or born with a lethal condition requiring hospice or palliative care (e.g., disease has progressed to NEC totalis, or patient has multi-organ system failure).
• • 3. Born with major congenital anomalies such as cardiac defects (e.g., Tetralogy of Fallot) or chromosomal disorders/anomalies (e.g., neural tube defect).
• • 4. Mother's receipt of any investigational product during pregnancy.
• • 5. Infants with malignancies (e.g., neoplastic cell growth as a solid tumor or a blood neoplasm, such as congenital leukemia).
• • 6. Infants with hypercoagulability disorders (any active thrombosis, diagnosis of disseminated intravascular coagulation or other acquired/inherited disorders (i.e., hemophilia) of coagulation.
• • 7. Infants with a known immunodeficiency (such as galactosemia or agranulocytosis).
• • 8. Infants with anatomic defects that require surgical intervention.
• • 9. Infants with persistent pulmonary hypertension of newborn.
• • 10. Infants with any congenital or acquired gastrointestinal pathology that preclude feeds within 7 days after birth (e.g., duodenal atresia).
• • 11. Infants who have hypoxic ischemic injury (perinatal asphyxia).
• • 12. Infants with polycythemia (at time of treatment) (\>22 g/dL).
• • 13. Positive maternal human immunodeficiency virus status.
• • 14. History of maternal drug abuse (such as amphetamines, opiates, cocaine). This does not include marijuana, or prescription medications for treatment of drug abuse.
• • 15. Considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
• • 16. Infants diagnosed with NEC who will require immediate surgical intervention.