Conducted in collaboration with the Blood Cancer Research Partnership and Dana-Farber Cancer Institute (DFCI), the trial is designed to evaluate the safety and efficacy of the combination of TGR-1202 and ibrutinib, an FDA-approved oral Bruton’s tyrosine kinase (BTK) in these patients.
The trial is enrolling patients with CLL and MCL whose disease is relapsed from or refractory to prior therapy, including prior PI3K Delta inhibitors, and/or BTK inhibitors.
TG Therapeutics executive chairman and interim chief executive officer Michael Weiss said: "TGR-1202 has continued to demonstrate a unique safety profile, particularly as it relates to liver toxicity, as compared to other PI3K delta inhibitors that we believe makes it well suited for combination therapy."
DFCI is the main center for the Phase I trial being lead by Dr Matthew Davids.
The trial is being supported in part by the Blood Cancer Research Partnership (BCRP), a network of sites for clinical trial testing of new blood cancer therapies, established by The Leukemia & Lymphoma Society (LLS) and DFCI.
Davids said: "In the past year, we have witnessed the approval of targeted oral agents such as ibrutinib that are well-tolerated and highly efficacious in CLL and other B cell malignancies.
"This therapeutic revolution has only just begun, and the critical next step will be to evaluate rational combinations of new oral agents to determine the safety and efficacy of combination therapy."