Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT)
Status:
Completed
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
Summary
The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to
evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients
undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment.
The study will be separated into two parts; a dose escalation phase to assess safety,
followed by a large expansion phase to further evaluate the pharmacologic effects of either a
Maximum Tolerated Dose, Maximum Feasible Dose or optimal pharmacologically active dose of
RGI-2001. The initial dose escalation safety portion of the study (Part 1) will include
higher risk patients and limit the unrelated donor transplants. After safety is established
in part 1 of the study, the second portion of the study will expand the enrollment criteria
and allow transplantation by either related or unrelated donors.
This study will endeavor to identify the dose range at which RGI-2001 has an acceptable
safety profile, at which biologic activity is observed, and to guide possible dose levels to
utilize in later phase studies based on biological activity.