Phase I Study of GNKG168 in Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia
Status:
Terminated
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
This is a phase I trial of an investigational drug called GNKG168 in patients with relapsed
and refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) who
are in morphologic remission but are positive for Minimum Residual Disease (MRD). GNKG168 is
a Toll-like receptor (TLR) agonist. TLR agonists are a novel approach to stimulate an
effective anti-tumor immune response as they are able to stimulate both innate and adaptive
immune responses. There will be two strata i.e patients who have received hematopoietic stem
cell transplant (HSCT) and patients who have never undergone HSCT. GNKG168 will be
administered as a 60 min iv infusion. One 14-day cycle consists of 5-day treatment followed
by 9 day-rest. Patients will receive 2 cycles before evaluation. The primary objective is to
determine the maximum tolerated dose of GNKG168 in relapsed ALL and AML patients.
Phase:
Phase 1
Details
Lead Sponsor:
Therapeutic Advances in Childhood Leukemia Consortium