Relapsed or refractory GD2-positive solid tumors (i.e., neuroblastoma, glioma, or osteosarcoma) CAR Immunotherapy GD2-positive solid tumor Neuroblastoma Glioma Osteosarcoma
Conditions
Interventions
The intervention is an immune-cellular therapy that involves the genetic modification of autologous T-cells ex vivo through a lentiviral vector that encodes an anti-GD2 CAR.
Experimental Biological/Vaccine
Autologous Anti-GD2 Chimeric Antigen Receptor T Cells
Sponsors
Chiang Mai University
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
No minimum to 60 Years
Inclusion criteria
Inclusion criteria: 1. Relapsed or refractory GD2-positive neuroblastoma, glioma, or osteosarcoma 2. Age criteria between 18 months and 25 years (for neuroblastoma) and from birth to 60 years (for glioma or osteosarcoma) 3. Measurable or evaluable disease 4. Estimated life expectancy of >2 months 5. Eligible for leukapheresis/venipuncture and autologous T cell infusion 6. Able to provide written informed consent or assent 7. Agree to use an acceptable contraceptive method(s)
Exclusion criteria
Exclusion criteria: 1. Previous treatment with other genetically engineered GD2-specific CAR-T cells or anti-GD2 antibodies 2. Rapidly progressive disease 3. Inadequate performance status 4. Inadequate organ function 5. History of autoimmune disease, or other diseases requiring long-term administration of systemic steroids or immunosuppressive therapies 6. History of severe hypersensitivity or contraindication to any component of the lymphodepleting regimen or the investigational product 7. Active infection 8. History of any illness(es) or any clinical condition(s) that might confound the results of the study or pose an additional risk in administering the investigational product to the patient 9. Positive serology 10. Participation in another clinical trial with an investigational drug or device 11. Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose Days 0, 1, 2, 3, 5, 7, 14, 21, 28 Hematologic and non-hematologic toxicities,Safety assessment Days -5, -4, -3, 0, 1, 2, 3, 5, 7, 14, 21, 28; Months 2, 3, 4, 5, 6, 9, 12; Years 2, 3, 4 CTCAE assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate Day 28; Months 3, 6, 9, 12; Years 2, 3, 4 RECIST criteria v1.1 / immune-related response criteria (e.g., INRC, irRC, RANO), as appropriate by tumor type,Response to therapy (neuroblastoma) Screening; Day 28; Months 3, 6, 9, 12; Years 2, 3, 4 131I-MIBG-SPECT,Response to therapy (for neuroblastoma and osteosarcoma) Screening; Day 28 PET scan,Overall survival rate Days 0, 1, 2, 3, 5, 7, 14, 21, 28; Months 2, 3, 4, 5, 6, 9, 12; Years 2, 3, 4 Mortality,Progression-free survival rate Screening; Day 28; Months 3, 6, 9, 12; Years 2, 3, 4 Tumor assessment (by CT scan and/or MRI),Expansion and persistence of GD2 CAR T in bone marrow (exploratory) Pre-infusion; Day 28; Months 3, 6, 9, 12; Years 2, 3, 4 Bone marrow aspiration and/or biopsy,Tumor infiltration (exploratory) Screening; Day 28; Months 3, 6, 12; Years 2, 3, 4 Tumor biopsy,Serum cytokine and chemokine levels (exploratory) Days 0, 1, 2, 3, 5, 7, 14, 21, 28; Months 2, 3, 4, 5, 6, 9, 12; Years 2, 3, 4 ELISA,Biomarkers Days 0, 1, 2, 3, 5, 7, 14, 21, 28; Months 2, 3, 4, 5, 6, 9, 12; Years 2, 3, 4 Tumor markers, cell-free DNA, extracellular vesicle ,Expansion and persistence of GD2 CAR T in peripheral blood (exploratory) Days 0, 1, 2, 3, 5, 7, 14, 21, 28; Months 2, 3, 4, 5, 6, 9, 12; Years 2, 3, 4 Droplet digital PCR and/or flow cytometry,Genome profiles Day 0 Whole exome sequencing | — |
Countries
Thailand
Contacts
Public ContactDumnoensun Pruksakorn
Faculty of Medicine, Chiang Mai University
Outcome results
None listed