GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma and Metastatic Retinoblastoma (NCT05650749) | Clinical Trial Compass
RecruitingPhase 1
GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma and Metastatic Retinoblastoma
United States45 participantsStarted 2023-05-23
Plain-language summary
This is a first in human dose escalation trial to determine the safety of administering GPC2 CAR T cells in patients with advanced neuroblastoma or retinoblastoma.
Who can participate
Age range1 Year
SexALL
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Inclusion criteria
✓. Patients must be ≥ 1 year of age
✓. Patients must have high-risk neuroblastoma according to COG risk classification at the time of study enrollment. Patients who were initially considered low- or intermediate-risk, but then reclassified as high-risk are also eligible.
✓. Patients must have a previously histologically confirmed diagnosis of neuroblastoma:
✓. That is recurrent/relapsed or refractory/persistent according to INRC AND
✓. For which standard curative measures do not exist or are no longer effective.
✓. patients at first relapse are eligible as no known curative therapies exist for relapsed high-risk neuroblastoma.
✓. Patients must have evaluable or measurable disease at enrollment.
✓. In addition, patient must have experienced at least one of the following:
Exclusion criteria
✕. Patients with active hepatitis B or active hepatitis C.
✕. Patients with HIV infection.
✕. Patients with uncontrolled active infection.
✕. Patients with primary or acquired immunodeficiency disorder.
✕. Patients with a known hypersensitivity to DMSO.
What they're measuring
1
Determine the Maximum Tolerated Dose of GPC2 CAR T cells
Timeframe: 5 years
2
Frequency of Adverse Events Following GPC2 CAR T cell administration
✕. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
✕. Patients with actively progressing CNS metastases, including parenchymal or leptomeningeal involvement. (Note: CNS imaging at screening is only required if the there is a clinical indication of suspected CNS metastasis)
✕. Active medical disorder that, in the opinion of the investigator, would substantially increase the risk of uncontrollable CRS and/or neurotoxicity.