GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma

Launched by STEPHAN GRUPP MD PHD · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GPC2 CAR T cells for children with advanced neuroblastoma, a type of cancer. Specifically, it's looking at how safe this treatment is for kids who have high-risk neuroblastoma that has either come back after treatment or has not responded to previous therapies. The trial is currently recruiting participants who are at least one year old and meet certain health criteria. For example, they need to have a confirmed diagnosis of neuroblastoma that is still measurable, and their overall health must be good enough to participate.

If you or your child decide to participate, you would receive the GPC2 CAR T cell treatment, which is a type of therapy that uses modified immune cells to help fight the cancer. Throughout the trial, doctors will closely monitor participants for any side effects and how well the treatment is working. It's important to know that some children may not be eligible, especially those with certain infections or serious health issues. Overall, this trial aims to explore a promising new option for treating tough cases of neuroblastoma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed Informed Consent Form
• • 2. ≥ 1 year of age
• • 3. Disease status
• • 1. Patients must have high-risk neuroblastoma according to Children's Oncology Group risk classification at the time of study enrollment.
• • 2. Histologically confirmed diagnosis of neuroblastoma that is recurrent/relapsed/persistent according to International Neuroblastoma Response Criteria
• • 3. Patients must have evaluable or measurable disease at enrollment
• • 4. Adequate organ function
• • 5. Adequate performance status defined as Lanksy or Karnofsky performance score ≥60.
• • 6. Subjects of reproductive potential must agree to use acceptable birth control methods.
• Exclusion Criteria:
• • 1. Patients with active hepatitis B or active hepatitis C.
• • 2. Patients with HIV infection.
• • 3. Patients with uncontrolled active infection
• • 4. Patients with primary or acquired immunodeficiency disorder.
• • 5. 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.
• • 6. Patients with actively progressing Central Nervous System metastases, including parenchymal or leptomeningeal involvement.
• • 7. Active medical disorder that, in the opinion of the investigator, would substantially increase. the risk of uncontrollable Cytokine Release Syndrome and/or neurotoxicity.
• • 8. Patients with congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.
• • 9. Patients who have received any live vaccines within 30 days prior to enrollment.
• • 10. Pregnant or nursing (lactating) women.

Trial Officials