CAR T-Cell Therapy for Neuroblastoma and Osteosarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a novel treatment combining CAR T-cells targeting GD2 with IL-15 and an off switch mechanism using iCaspase9 for patients with relapsed or refractory neuroblastoma and osteosarcoma. The approach aims to enhance the effectiveness of T-cells in recognizing and destroying cancer cells while providing a safety mechanism to mitigate severe side effects. Participants will undergo a preparatory regimen followed by the infusion of modified T-cells, with careful monitoring for efficacy and safety. The study is multicenter, involving collaboration with prominent cancer research institutions.

Why it matters

Who can join: the full rules

All clinical and laboratory data required for determining eligibility must be available in the subject's medical/research record which will serve as the source document.

Because of the nature of iC9.GD2.CAR.IL-15 T cell product preparation, subjects will be assessed for initial study enrollment eligibility (prior to cell procurement) and then will have to meet criteria prior to starting lymphodepletion and prior to T cell infusion.

Inclusion Criteria for the Study:

1. Written HIPAA authorization signed by legal guardian.
2. Adequate performance status as defined by Lansky or Karnofsky performance status of ≥ 60 (Lansky for \<16 years of age).
3. Life expectancy ≥12 weeks.
4. Histological confirmation of neuroblastoma or ganglioneuroblastoma at initial diagnosis. Bone marrow samples are acceptable as confirmation of neuroblastoma, confirmation of osteosarcoma at diagnosis
5. High-risk neuroblastoma with persistent/refractory or relapsed disease, defined as:

   1. First or greater relapse of neuroblastoma following completion of aggressive multi-drug frontline therapy.
   2. First episode of progressive neuroblastoma during aggressive multi-drug frontline therapy. Persistent/refractory neuroblastoma as defined by less than a complete response by the revised International Neuroblastoma Response Criteria (INRC) at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (such as A3973 or ANBL0532).
   3. Patients must be diagnosed with high risk neuroblastoma at initial diagnosis or if non-high risk at time of initial diagnosis must have had evidence of metastatic progression when \>18 months of age as defined in the protocol or relapsed or refractory osteosarcoma that is not responsive to standard treatment.
6. Measurable or evaluable disease per Revised INRC for subjects with neuroblastoma or measurable disease by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 criteria for subjects with osteosarcoma.
7. Adequate central nervous system function as defined by:

   1. No known Central Nervous System ( CNS) disease
   2. No seizure disorder requiring antiepileptic drug therapy

Exclusion Criteria for the Study Subjects meeting any of the following exclusion criteria will not be able to participate in this study (procurement, lymphodepletion, and cell infusion).

1. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
2. Has a known additional malignancy that is active and/or progressive requiring treatment.
3. History of hypersensitivity reactions to murine protein-containing products.
4. History of hypersensitivity to cyclophosphamide or fludarabine.

Where it's running

• Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Emory - Winship Cancer Institute
  Atlanta, Georgia, United States Withdrawn

Study contacts

• Principal investigator: George Hucks, MD — UNC Lineberger Comprehensive Cancer Center

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.