Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma
Фаза 1
Идёт, набор закрыт
NCT03696784
| Заболевание | Lymphoma, Lymphoma, B-Cell, Immune System Diseases, Immunoproliferative Disorders |
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| Фаза | Фаза 1 |
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| Спонсор | UNC Lineberger Comprehensive Cancer Center |
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| Статус | Идёт, набор закрыт |
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| Участники | 12 участн. |
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| Вмешательство | iC9-CAR19 T cells, Bendamustine, Fludarabine, AP1903, Cyclophosphamide |
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| Дата начала | 12.03.2019 |
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| Дата завершения | 31.08.2025 |
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| Публикация результатов | 31.07.2026 |
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Кратко
This research study combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. This study combines both T cells and antibodies to create a more effective treatment. The treatment being researched is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD19 antigen (ATLCAR.CD19) administration. Prior studies have shown that a new gene can be put into T cells and will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD19. This antibody sticks to leukemia cells because they have a substance on the outside of the cells called CD19. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD19 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long i
Number of Participants With Treatment-emergent Grade ≥ 3 Adverse Events Per National Cancer Institute's Common Terminology Criteria
Up to 4 weeks · Participants
| Cohort1A | 1 Participants |
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| Cohort1B | 0 Participants |
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| Cohort2 | 3 Participants |
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| Cohort1A | 0 Participants |
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| Cohort1B | 0 Participants |
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| Cohort2 | 2 Participants |
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Number of Participants With Treatment-emergent Grade ≥ 3 Adverse Events Per Cytokine Release Syndrome (CRS)
Up to 4 weeks · Participants
| Cohort1A | 0 Participants |
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| Cohort1B | 0 Participants |
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| Cohort2 | 0 Participants |
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Number of Participants With Treatment-emergent Grade ≥ 3 Adverse Events Per Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)
Up to 4 weeks · Participants
| Cohort1A | 0 Participants |
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| Cohort1B | 0 Participants |
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| Cohort2 | 0 Participants |
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