JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia
Status:
Completed
Trial end date:
2017-02-20
Target enrollment:
Participant gender:
Summary
This is a Phase 1, open-label, dose escalation study of JVRS-100. The study will proceed in 2
stages to minimize the number of patients treated at doses substantially below the
recommended phase 2 dose. In stage 1, an accelerated titration schema will be followed with
one patient at each dose level. Stage 2 will commence after a dose limiting toxicity is
observed in stage 1 or after the maximum dose for stage 1 is reached. Stage 2 will follow a
modified Fibonacci schema with 3-6 subjects at each dose level until a recommended phase 2
dose is determined. The cohort will then be expanded to a maximum of 12 patients to more
fully evaluate the recommended phase 2 dose.