Status:
ACTIVE_NOT_RECRUITING
3rd Generation GD-2 Chimeric Antigen Receptor and ICaspase Suicide Safety Switch, Neuroblastoma, GRAIN
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Neuroblastoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeri...
Detailed Description
We will make iC9-GD2 T cells by infecting normal T cells with a retroviral vector containing the iC9-GD2 gene. After the new gene has been put into the T cells, the cells will be tested to make sure t...
Eligibility Criteria
Inclusion
- PROCUREMENT
- High risk neuroblastoma with persistent or relapsed disease
- Life expectancy of at least 12 weeks
- Karnofsky/Lansky score of 60% or greater
- Absence of HAMA prior to enrollment (only in patients that have been previously treated with murine antibodies)
- Informed consent and assent (as applicable) obtained from parent/guardian and child
- TREATMENT:
- High risk neuroblastoma with persistent or relapsed disease
- Life expectancy of at least 12 weeks
- Karnofsky/Lansky score of 60% or greater
- Patients must have an ANC greater than or equal to 500, platelet count greater than or equal to 20,000
- Pulse Ox greater than or equal to 90% on room air
- AST and ALT less than 5 times the upper limit of normal
- Total bilirubin less than 3 times the upper limit of normal
- Serum creatinine less than 3 times upper limit of normal. Creatinine clearance is needed for patients with creatinine greater than 1.5 times upper limit of normal
- TSH normal for age. Patients using thyroid medication to facilitate a euthyroid state must be on a stable dose for at least 1 month prior to planned infusion
- Recovered from acute effects of all prior chemotherapy. If some effects of therapy have become chronic (i.e., treatment associated thrombocytopenia), the patient must be clinically stable and meet all other eligibility criteria
- Absence of human anti-mouse antibodies (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies
- Patients must have autologous transduced activated T-cells with greater than or equal to 20% expression of GD2
- Pembrolizumab available for infusion
- Informed consent and assent (as applicable) obtained from parent/guardian and child
Exclusion
- PROCUREMENT:
- Rapidly progressive disease
- History of hypersensitivity to murine protein containing products
- TREATMENT:
- Rapidly progressive disease
- Currently receiving other investigational drugs
- History of hypersensitivity to murine protein containing products
- History of cardiomegaly or bilateral pulmonary infiltrates on chest radiograph or CT. However, patients with cardiomegaly on imaging may be enrolled if they have an assessment of cardiac function (i.e., ECHO or MUGA) within 3 weeks of starting protocol therapy that is within normal limits. Additionally, patients with bilateral pulmonary infiltrates on imaging may be enrolled if the lesions are not consistent with active neuroblastoma (i.e., negative on functional imaging with PET or MIBG, or by pathologic assessment).
- Evidence of tumor potentially causing airway obstruction
- Patients who are pregnant, lactating, or unwilling to use birth control
- Patients currently receiving immunosuppressive drugs such as corticosteroids, tacrolimus or cyclosporine
- Patients previously experienced severe toxicity from cyclophosphamide or fludarabine
- Severe previous toxicity from pembrolizumab or other PD-1 targeted antibody
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2030
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01822652
Start Date
August 1 2013
End Date
October 1 2030
Last Update
February 24 2025
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030