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CAR T-Cells Targeting the GD2 Antigen for Relapsed/Refractory Neuroblastoma orRelapsed/Refractory Neuroblastoma and Osteosarcoma

The purpose of this study is to establish a safe and effective dose of CAR-T cells for patients with Relapsed or Refractory Neuroblastoma or Osteosarcoma.

Age & Gender

  • 0 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

Your blood will be collected so that the manufacturing process to make modified T cells can begin. The modified study cells will hopefully be more effective at killing your cancer cells than your body's normal immune cells. The study team will do blood tests and other procedures to confirm it is safe for you to get the modified study cells. If it is safe, you will complete four days of pre-treatment (chemotherapy) that will prepare your body to accept the study cells better. You will then receive the study cell infusion. You will have to stay near the hospital after infusion and will be seen frequently in clinic for follow-up visits that may include lab tests, imaging, or biopsies of your tumor. You will continue follow up visits based on how well you have responded to the study treatment.

In-person visits:
Minimum of 14 through first year of participation; likely more depending on side effects
Phone or online visits:
Visits all in person unless disease has worsened, then can be contacted by phone during follow up
Total length of participation:
1 year for treatment and initial follow-up, long term follow-up for 15 years

Looking for Specific Volunteers

Able to participate:

  • You have been diagnosed with neuroblastoma or osteosarcoma
  • You have relapsed or refractory disease after prior treatment

Not eligible if:

  • You are taking corticosteroids at doses of 10 mg or more of prednisone
  • Active infection with HIV, HTLV, Hepatitis B or Hepatitis C
  • Known involvement of disease in the brain or spinal cord (central nervous system) or seizure disorder requiring anti-epileptic drug treatment

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

George Hucks
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Brain and Other Nervous System, Sarcoma (bone and soft tissue))

IRB Number

18-1275

ClinicalTrials.gov

NCT03721068

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