Genetically Modified T Cells (B7-H3-CAR T cells) for of Treatment of Relapsed or Refractory Solid Tumors

Inclusion Criteria

• PROCUREMENT AND T-CELL PROCUREMENT: Age =< 21 years old
• PROCUREMENT AND T-CELL PROCUREMENT: B7-H3+ solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using a previously obtained biopsy; a tumor is considered B7-H3 positive with an H-score of >= 100
• PROCUREMENT AND T-CELL PROCUREMENT: Evidence of relapsed (cancer that has completely responded [i.e. no evidence of disease using standard imaging modalities] to first-line therapy but has recurred for the first or subsequent time); or refractory (cancer that does not respond to treatment; the cancer may be resistant at the beginning or may become resistant during treatment) disease after standard first-line therapy
• PROCUREMENT AND T-CELL PROCUREMENT: Measurable or evaluable disease
• PROCUREMENT AND T-CELL PROCUREMENT: Estimated life expectancy of > 12 weeks
• PROCUREMENT AND T-CELL PROCUREMENT: Karnofsky or Lansky (age-dependent) performance score >= 60
• PROCUREMENT AND T-CELL PROCUREMENT: For females of child bearing age: * Not pregnant with negative serum pregnancy test within 7 days prior to enrollment * Not lactating with intent to breastfeed
• PROCUREMENT AND T-CELL PROCUREMENT: Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis
• TREATMENT: Age =< 21 years old at the time of CAR T-cell production
• TREATMENT: B7-H3+ solid tumor with measurable disease
• TREATMENT: Evidence of relapsed or refractory disease after standard first-line therapy
• TREATMENT: Measurable or evaluable disease
• TREATMENT: Estimated life expectancy of > 8 weeks
• TREATMENT: Karnofsky or Lansky (age-dependent) performance score >= 60
• TREATMENT: Echocardiogram with a left ventricular ejection fraction >= 50%
• TREATMENT: Calculated creatinine clearance 60 ml/min/1.73m^2 (glomerular filtration rate [GFR] 60 ml/min/1.73m^2 by Cockcroft-Gault formulation if < 2 years of age)
• TREATMENT: Pulse oximetry >= 92% on room air or forced vital capacity (FVC) >= 50% of predicted value
• TREATMENT: Total bilirubin =< 3 times the upper limit of normal for age, except in subjects with Gilbert’s syndrome
• TREATMENT: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 5 times the upper limit of normal for age
• TREATMENT: Hemoglobin >= 7g/dL (can be transfused)
• TREATMENT: Platelet count >= 50,000/uL (can be transfused)
• TREATMENT: Absolute neutrophil count (ANC) >= 1000/uL
• TREATMENT: Has recovered from all National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade III-IV, non-hematologic acute toxicities from prior therapy
• TREATMENT: For females of child bearing age: * Not pregnant with negative serum pregnancy test within 7 days prior to enrollment * Not lactating with intent to breastfeed * If sexually active, agreement to use birth control until 3 months after T-cell infusion. Male partners should use a condom
• TREATMENT: Available autologous transduced T-cell product that has met GMP release criteria

Exclusion Criteria

• PROCUREMENT AND T-CELL PROCUREMENT: Known primary immunodeficiency or acquired immunodeficiency
• PROCUREMENT AND T-CELL PROCUREMENT: Known human immunodeficiency virus (HIV) positivity
• PROCUREMENT AND T-CELL PROCUREMENT: Severe intercurrent bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)
• PROCUREMENT AND T-CELL PROCUREMENT: Rapidly progressive disease (in the opinion of the study principal investigator [PI]s)
• PROCUREMENT AND T-CELL PROCUREMENT: Known underlying medical condition for which, in the investigator’s opinion, participation in this trial would not be in the best interest of the participant (e.g., compromises the health of the subject) or that could prevent, limit or confound protocol assessments
• PROCUREMENT AND T-CELL PROCUREMENT: Known severe hypersensitivity to corn starch or hydroxyethyl starch
• TREATMENT: Known primary immunodeficiency or acquired immunodeficiency
• TREATMENT: History of HIV positivity
• TREATMENT: Severe, uncontrolled intercurrent bacterial, viral or fungal infection
• TREATMENT: Myocardial infarction, unstable angina, New York Heart Association class III and IV congestive heart failure, myocarditis, or ventricular arrhythmias requiring medication within 6 months prior to study entry
• TREATMENT: Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, or any other form of immunosuppressive therapy (excluding subjects with hypothyroidism who are stable on hormone replacement) for at least two weeks prior to trial treatment
• TREATMENT: Receiving systemic therapy in the 14 days prior to CAR T-cell infusion, which will interfere with the activity of the B7-H3-CAR product (in the opinion of the study PIs)
• TREATMENT: Rapidly progressing disease (in the opinion of the study PIs)
• TREATMENT: Received any live vaccines within 30 days prior to enrollment
• TREATMENT: Active infection requiring systemic therapy or causing fever (temperature > 38.1 degree Celsius) or subjects with unexplained fever (temperature > 38.1°C) within 48 hours prior to the start of protocol-defined treatment
• TREATMENT: Known underlying medical condition for which, in the investigator’s opinion, participation in this trial would not be in the best interest of the participant (e.g., compromises the health of the subject) or that could prevent, limit or confound protocol assessments
• TREATMENT: Known severe hypersensitivity to corn starch or hydroxyethyl starch
• TREATMENT: Adult patient, parent, or legal guardian is unwilling or unable to provide consent for participation in a 15 year long-term follow up study