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22CT012: GPC2 CAR T Cell Trial
This study is now recruiting.
The purpose of this study is to test an experimental approach called cell therapy for neuroblastoma or retinoblastoma. This study will take a patient's own white blood cells (T cells) and change them to turn against the cancer. These cells are an experimental treatment and have not been approved by the FDA. CAR T cells have been used to treat other cancers, but GPC2 CAR T cells have not been administered to human patients prior to this clinical trial.
If they choose to participate in this study, active participation will last approximately 12 months. Participants will also be asked to sign consent to a separate long term follow-up protocol to monitor their health for up to 15 years after their last GPC2 CAR T treatment.
This study will assess the safety and effectiveness of GPC2 CAR T cells. Overall, approximately 45 subjects will be enrolled on this study.
Who Do I Contact?
If you are interested in participating in the study or want to learn more please contact our study team at cartnursenavigator [at] chop.edu or 445-942-5891.
ClinicalTrials.gov Identifier
Eligibility & Criteria
IRB #:
22-019659
Official Title:
Phase 1 Trial of GPC2-Directed Chimeric Antigen Receptor Autologous T cells (GPC2 CAR T) for Relapsed or Refractory Neuroblastoma and Metastatic Retinoblastoma
Study Phase:
Phase I
Eligible Age Range:
1 - 29 Years
Gender:
All
Visit Criteria
This study will take place at the Children's Hospital of Philadelphia.
Active participation lasts for 12 months. Study visits will occur at the following cadence: Screening/Enrollment, Pre-Infusion, Day -1, Infusion (Day 0), Day 1, Day 3, Day 7, Day 10, Day 14, Day 21, Day 28, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, and Month 12
Possible procedures include:
- medical record review
- apheresis
- GPC2 CAR T cell infusion
- blood draws
- physical exams
- imaging
- disease assessments through bone marrows and lumbar punctures
Leaders
