A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients with DIPG

Exclusion criteria

• . Evidence of progressive disease by radiologic criteria (RAPNO for subjects ≤ 21 years of age or mRANO for subjects \> 21 years of age).
• . Increasing steroid dose prior to Day 1.
• . Diagnosis of porphyria.
• . Hypersensitivity against porphyrins.
• . Current malignancies or relevant history of other malignancy, physical, or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
• . Known history of human immunodeficiency virus (HIV), hepatitis B or C infection, or any active systemic infection.
• . Use of potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, tetracyclines, sulfonamides, quinolones, hypericin extracts, topical preparations containing ALA) within 24 hours before and after SONALA-001 infusion.
• . Prior or concurrent therapy with any other anticancer (including radiotherapy, with the exception of radiotherapy administered per inclusion criteria #2 and #3) or investigational drug or other investigational intervention. NOTE: The use of bevacizumab or similar agent to control radiation therapy-induced edema is allowed for up to a maximum of 5 doses. The last dose must have been administered no later than 14 days prior to Day 1. See Section 6 (Prior and Concomitant Treatment) for a list of prohibited and restricted medications.