Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma

Phase 1 Active, not recruiting NCT03696784

Summary

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

Number of Participants With Treatment-emergent Grade ≥ 3 Adverse Events Per Cytokine Release Syndrome (CRS)

Up to 4 weeks · Participants

Number of Participants With Treatment-emergent Grade ≥ 3 Adverse Events Per Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)

Up to 4 weeks · Participants

Open in BENITIONS View on ClinicalTrials.gov

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