NCT04102436 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Deniger DC, Switzer K, Mi T, Maiti S, Hurton L, Singh H, Huls H, Olivares S, Lee DA, Champlin RE, Cooper LJ
Bispecific T-cells expressing polyclonal repertoire of endogenous gammadelta T-cell receptors and introduced CD19-specific chimeric antigen receptor. Mol Ther. 2013 Mar;21(3):638-47. doi: 10.1038/mt.2012.267. Epub 2013 Jan 8.
Ivics Z, Hackett PB, Plasterk RH, Izsvak Z
Molecular reconstruction of Sleeping Beauty, a Tc1-like transposon from fish, and its transposition in human cells. Cell. 1997 Nov 14;91(4):501-10. doi: 10.1016/s0092-8674(00)80436-5.
Maiti SN, Huls H, Singh H, Dawson M, Figliola M, Olivares S, Rao P, Zhao YJ, Multani A, Yang G, Zhang L, Crossland D, Ang S, Torikai H, Rabinovich B, Lee DA, Kebriaei P, Hackett P, Champlin RE, Cooper LJ
Sleeping beauty system to redirect T-cell specificity for human applications. J Immunother. 2013 Feb;36(2):112-23. doi: 10.1097/CJI.0b013e3182811ce9.

A Phase II Study Using the Administration of Autologous T-Cells Engineered Using the Sleeping Beauty Transposon/Transposase System to Express T-Cell Receptors Reactive Against Mutated Neoantigens in Patients With Metastatic Cancer

Details for clinical trial NCT04102436

Clinical trial NCT04102436 - References