GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT)

Inclusion Criteria

• •1\) Diagnosis of GPC3-positive recurrent ATRT.
• •2\) Age ≥ 6 months
• •3\) Karnofsky/Lansky score ≥ 60%
• •4\) Informed consent explained to, understood by, and signed by patient/guardian; copy provided
• •5\) GPC3 expression by immunohistochemistry with extent score ≥ Grade 2 (\>25% positive tumor cells) and intensity score ≥ 2 (scale 0-4)
• •1\) Age ≥ 6 months
• •2\) Diagnosis of treatment refractory or unresectable ATRT after standard of care therapy
• •3\) Lansky/Karnofsky score ≥ 60%
• •4\) Stable neurologic exam for 7 days prior to enrollment
• •5\) Stable or decreasing dose of steroids over past 7 days prior to surgery and administration of therapy (max allowable dose is 0.1mg/kg dexamethasone or equivalent per day)
• •6\) Not receiving any concurrent anti-cancer therapy.
• •7\) At least 6 weeks following craniospinal radiation therapy.
• •8\) At least 14 days wash-out needed following small volume radiotherapy (i.e., Stereotactic Radiosurgery (SRS)).
• •9\) At least 21 days or 5 half-lives (whichever is shorter) must have elapsed since any prior systemic therapy
• •10\) Received any other forms of immunotherapy ≤ 42 days before administration of investigational agent
• •11\) At least 28 days following bevacizumab
• •12\) Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min
• •13\) Total bilirubin \< 3 times ULN for age
• •14\) INR ≤ 1.7
• •15\) Absolute neutrophil count \> 500/μl
• •16\) Platelet count \> 100,000/μl (can be transfused but must be achieved prior to enrollment)
• •17\) Hgb ≥ 7.0 g/dl (can be transfused)
• •18\) Pulse oximetry \> 90% on room air
• •19\) Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study
• •20\) Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.
• •21\) Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent