B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

Procurement and T-cell production eligibility\*

\*a previously collected, autologous leukapheresis product can be used for T-cell production

* Age ≤21 years old
* 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 ≥100
* Estimated life expectancy of \>12 weeks
* Karnofsky or Lansky (age-dependent) performance score ≥50
* 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
* Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis

Exclusion Criteria:

* Known primary immunodeficiency
* Known HIV positivity
* Severe intercurrent bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)
* History of hypersensitivity reactions to murine protein-containing products
* Rapidly progressive disease (in the opinion of the study PIs)

Inclusion criteria

Treatment eligibility

* Age ≤21 years old
* B7-H3+ solid tumor with measurable disease
* Evidence of relapsed or refractory disease after standard first-line therapy
* Estimated life expectancy of \>8 weeks
* Karnofsky or Lansky (age-dependent) performance score≥50
* Echocardiogram with a ventricular ejection fraction
* \>40%; or shortening fraction ≥25%
* Adequate renal function defined as creatinine clearance or radioisotope GFR 50 ml/min/1.73m2 (GFR 40 ml/min/1.73m2 if \< 2 years of age)
* Adequate pulmonary function defined as pulse oximetry ≥92% on room air or forced vital capacity (FVC) ≥50% of predicted value
* Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age
* Hemoglobin≥ 7g/dL (can be transfused)
* Platelet count \>50,000/uL (can be transfused)
* Absolute neutrophil count (ANC) ≥ 1000/uL
* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
* 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.
* Available autologous transduced T-cell product that has met GMP release criteria
* Agreement to participate in long-term follow-up protocol for patients, who have received genetically modified cell products

Exclusion criteria

* Known primary immunodeficiency
* History of HIV infection
* Severe, uncontrolled intercurrent bacterial, viral or fungal infection
* History of hypersensitivity reactions to murine protein-containing products
* Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, in the 7 days prior to B7-H3-CAR T-cell infusion
* 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).
* Rapidly progressing disease (in the opinion of the study PIs)