Anti-GD2 CAR T Cells in Pediatric Patients Affected by High Risk and/or Relapsed/Refractory Neuro… (NCT03373097) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Anti-GD2 CAR T Cells in Pediatric Patients Affected by High Risk and/or Relapsed/Refractory Neuroblastoma or Other GD2-positive Solid Tumors
Italy42 participantsStarted 2018-01-05
Plain-language summary
The purpose of this study is to test the safety and efficacy of GD2-CART01, a CAR T cell treatment targeting GD2 in paediatric or young adult patients with High Risk and/or relapsed/refractory Neuroblastoma.
A small exploratory cohort of patients with GD2-positive tumors other than Neuroblastoma has also been included.
Who can participate
Age range12 Months – 25 Years
SexALL
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Inclusion criteria
✓. Diagnosis of NBL that have been treated with frontline therapy and is judged to be incurable, based upon the following criteria:
✓. Relapse after first-line treatment, proved by a positive 123-I-mMIBG-scan
✓. Persistence/progression of disease after the initiation of the upfront treatment
✓. Patients must have measurable or evaluable disease at the time of treatment enrollment, as shown by bone marrow biopsy/aspirate, US or CT/MRI scan or by 123-I-mMIBG scan.
✓. Recover from the toxic effect of previous chemotherapies: grade 4 and or 3 non-hematologic toxicities must have resolved to grade ≤2; if some effects of the therapies have become chronic (i.e. treatment associated thrombocytopenia), the patient must be clinically stable, according to the opinion of the treating physicians, and meet all other eligibility criteria.
✓. Age: 12 months -18 years.
✓. Voluntary informed consent is given. For subjects \< 18 years old their legal guardian must give informed consent. Pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate.
✓. Clinical performance status: Patients \> 16 years of age: Karnofsky greater than or equal to 60%; Patients less than or equal to 16 years of age: Lansky scale greater than or equal to 60%.
Exclusion criteria
✕. Pregnant or lactating women
✕
What they're measuring
1
Phase I - Identification of the dose limiting toxicity (DLT)
Timeframe: 4 weeks after T cell infusion
2
Phase II - Antitumor effect
Timeframe: Up to 6 months after T cell infusion
Trial details
NCT IDNCT03373097
SponsorBambino Gesù Hospital and Research Institute
. Severe, uncontrolled active intercurrent infections
✕. Active hepatitis B or hepatitis C infection
✕. HIV infection
✕. Rapidly progressive disease with life-expectancy \< 6 weeks
✕. History of grade 3 or 4 hypersensitivity to murine protein-containing products
✕. Hepatic function: Inadequate liver function defined as total bilirubin \> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \> 6 x ULN based on age and laboratory specific normal ranges
✕. Renal function: serum creatinine \> 3x ULN for age.