The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age1 Year to 26 Years
- SexAll
- Healthy volunteersNo
You may be able to join if
- Participants must be aged 1 and ≤ 26 years and weigh ≥10kg.
- Diagnosis of Diffuse Intrinsic Pontine Glioma (DIPG) based on imaging, with or without biopsy confirmation consistent with high-grade glioma or diffuse midline glioma
- Able to tolerate leukapheresis and other study procedures in the opinion of the Investigator.
- Central Nervous System (CNS) reservoir catheter present prior to first dose of study drug.
- Participant must have completed standard radiation therapy within 6 weeks of enrollment for participation.
- Performance Status of ≥ 60; mild to moderate restriction or better. Lansky (under 16 years of age) or Karnofsky (16 years of age or older).
- Adequate organ function and overall clinical status to participate, including stable or improving neurologic symptoms.
- Participants of childbearing/fathering potential must agree to use highly effective contraception from the time of enrollment through 12 months following the last T cell infusion.
- Participants with ventriculoperitoneal (VP) shunts need to have a programable system and be able to tolerate temporary adjustment of the shunt required for study treatment.
- Participant must meet all other health and safety criteria defined in the study protocol.
- Participant and/or authorized legal representative willing to provide consent/assent for study participation, including participation in the 15-year long term follow up period.
You cannot join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Previous tumor-directed therapy or treatment-directed clinical study other than standard radiation with or without temozolamide.
- Evidence of metastatic disease.
- Requirement of high or increasing doses of corticosteroids prior to participation.
- Severe swallowing difficulties or other significant clinical conditions that may interfere with participation.
- Presence of an active malignancy other than DIPG.
- Active or uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection based on protocol-required laboratory testing.
- Pregnant or breastfeeding.
- Presence of any condition that, in the Investigator's opinion, would prohibit the participant from undergoing treatment under this protocol.
Triangle