Safety and Efficacy of Intraventricular Infusion of B7H3 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell in Diffuse Intrinsic Pontine Glioma
A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cell with IL-7Ra signal targeting B7H3 in children with diffuse intrinsic pontine glioma (DIPG) patients after complete standard treatments.
• Participants must have diffuse intrinsic pontine glioma at any timepoint following completion of standard radiotherapy
• Age 1-18 years
• Sex: Male or female
• CNS reservoir catheter, such as an Ommaya or Rickham catheter, present in the proper location for CNS-directed therapy
• Performance status: Lansky or Karnofsky score \>= 60
• Life expectancy \>= 8 weeks
• Normal organ function:
⁃ 1 AST (SGOT) \< 5 times the upper limit of normal (ULN) 7.2 ALT (SGPT) \< 5 times the upper limit of normal (ULN) 7.3 Total bilirubin \< 3 times the upper limit of normal (ULN) 7.4 Creatinine \< 5 times the upper limit of normal (ULN) 7.5 SpO2 room air \>=90%
• Prior therapy wash-out before planned leukapheresis 8.1 \>= 7 days post last chemotherapy/biologic therapy administration 8.2 3 half-lives or 30 days, whichever is shorter after the last dose of antitumor antibody therapy 8.3 At least 30 days from most recent cellular infusion 8.4 All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with a maximum dexamethasone dose of 2.5 mg/m2/day. Corticosteroid physiologic replacement therapy is allowed
• Participants and/or legal guardians must have the ability to understand and willingness to sign a written informed consent and/or assent document