Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Phase 1
Active, not recruiting
NCT02208362
| Condition | Recurrent Glioblastoma, Recurrent Malignant Glioma, Recurrent WHO Grade II Glioma, Recurrent WHO Grade III Glioma |
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| Phase | Phase 1 |
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| Sponsor | City of Hope Medical Center |
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| Status | Active, not recruiting |
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| Enrollment | 65 participants |
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| Interventions | Arm 1: IL13Ra2-specific CAR Tcm cells, Arm 2: IL13Ra2-specific CAR Tcm cells, Arm 3: IL13Ra2-specific CAR Tcm cells, Arm 4: IL13Ra2-specific CAR Tcm cells, Arm 5: IL13Ra2-specific CAR Tn/mem cells |
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| Start date | May 18, 2015 |
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| Completion date | Feb 8, 2021 |
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| Results posted | Oct 30, 2024 |
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Summary
This phase I trial studies the side effects and best dose of genetically modified T-cell immunotherapy in treating patients with malignant glioma that has come back (recurrent) or has not responded to therapy (refractory). A T cell is a type of immune cell that can recognize and kill abnormal cells in the body. T cells are taken from the patient's blood and a modified gene is placed into them in the laboratory and this may help them recognize and kill glioma cells. Genetically modified T-cells may also help the body build an immune response against the tumor cells.
Number of Participants With Grade 3 or Higher Toxicity Related to CAR T Cells
An average of 11 months · Participants
| Arm 1 Dose Schedule 1 | 0 Participants |
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| Arm 2 Dose Schedule 1 | 0 Participants |
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| Arm 2 Dose Schedule 2 | 0 Participants |
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| Arm 2 Dose Schedule 3 | 0 Participants |
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| Arm 3 Dose Schedule 1 | 0 Participants |
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| Arm 3 Dose Schedule 2 | 0 Participants |
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Number of Participants Experiencing a Dose Limiting Toxicity (DLT)
Up to 1 week following the last course, up to a total of 4 weeks (not including optional courses 4-6) · Participants
| Arm 1 Dose Schedule 1 | 0 Participants |
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| Arm 2 Dose Schedule 1 | 0 Participants |
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| Arm 2 Dose Schedule 2 | 0 Participants |
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| Arm 2 Dose Schedule 3 | 0 Participants |
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| Arm 3 Dose Schedule 1 | 0 Participants |
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| Arm 3 Dose Schedule 2 | 0 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.