Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Oct 24, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for children and young adults with certain types of hard-to-treat cancers, specifically neuroblastoma and osteosarcoma. The treatment combines two powerful tools that the body uses to fight cancer: T cells, which are special blood cells that can kill cancer cells, and antibodies, which help the immune system recognize and attack harmful substances. The researchers are exploring a specific type of T cell, called CAR T cells, that are designed to target a molecule found on cancer cells known as GD2. This new treatment aims to improve outcomes for patients whose cancer has not responded to standard therapies.

To participate in this trial, patients must be between the ages of 5 and 17 and have been diagnosed with high-risk neuroblastoma or relapsed osteosarcoma that hasn’t improved with other treatments. They will need to have a medical assessment to ensure they meet certain health criteria. If eligible, participants can expect to receive specialized T cells that have been created just for them, along with other supportive treatments. It's important to know that patients who are pregnant, breastfeeding, or have certain other medical conditions may not be able to join this study. This trial is currently recruiting participants, and those who take part will be contributing to important research that could help improve cancer treatments for future patients.

Gender

ALL

Eligibility criteria

• • 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.