TG Therapeutics has started a multi-centre, Phase I trial of the combination of TG-1101 (ublituximab) and TGR-1202 in patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).
The trial will be the first to assess the safety and efficacy of the combination of the company's TG-1101, a new glycoengineered anti-CD20 monoclonal antibody, and TGR-1202 a one per day, PI3K Delta inhibitor.
In the trial, dosing of TGR-1202 will start at 800mg once a day (or QD) with dose escalation proceeding in a 3+3 design.
The MD Anderson Cancer Center will be the lead centre for the trial, which is entitled 'A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of TG-1101 (Ublituximab), a novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Combination with TGR-1202, a Novel PI3k Delta Inhibitor, in Patients with B-cell Malignancies'.
Patients with CLL and NHL whose disease is relapsed from or refractory to prior therapies, including prior anti-CD20 monoclonal antibodies, PI3K Delta inhibitors, and BTK inhibitors, will be enrolled in the trial.
Furthermore, the company has also opened its first expansion cohort in its ongoing single agent Phase I dose escalation trial of TGR-1202.
Additional patients at the 800mg QD dose level will be enrolled in the expansion cohort, and the company said that dose escalation will continue in the trial as a maximum tolerated dose has not been reached.
TG Therapeutics executive chairman and interim CEO Michael Weiss said: "The commencement of this combination study today represents a major milestone for the company and is the beginning of what we expect to be a robust combination clinical programme, which will include our much anticipated combination of TG-1101 with ibrutinib."
The company intends to present detailed pharmacokinetic and safety data for all patients in the ongoing single agent study of TGR-1202 through the 1,200mg QD cohort as well as efficacy data through the 800mg QD dose escalation cohort at the upcoming American Society of Hematology Meeting (ASH) in December 2013.
Image: A high-magnification micrograph of B-cell chronic lymphocytic leukemia. Photo: courtesy of Nephron.