We are currently enrolling and treating patients in a Phase 1a/b multicenter, open-label, dose-escalation clinical trial of CG-806 in patients with relapsed or refractory B-cell malignancies, including CLL and NHL that have failed other therapies due to drug resistance, intolerance, or refractory disease. The study is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic responses, and preliminary efficacy of CG-806, and establish the recommended Phase 2 dose.
On Nov. 05, 2019, we announced that that we have completed an accelerated titration through the first two dose levels 150 mg and 300 mg BID by enrolling and treating only one patient per cohort (both heavily pre-treated CLL patients). We have observed dose related and well-behaved PK properties such that steady state was reached by the end of the first week of dosing. A data review conducted at the end of October 2019 showed: (a) both patients continuing on study, with the first patient dosing on the 5th cycle and the second on the 3rd cycle; (b) no SAEs, no drug-related toxicities, and no myelosuppression. Of note, in the CLL patient on the second dose level, we observed robust sustained lymphocytosis as well as reduction in tumor burden across multiple index nodes and no new hypermetabolic foci at the first scheduled FDG-PET/CT scan.
Now, we are enrolling and screening patients for the third dose cohort (450 mg BID), to be followed by ascending cohorts with three patients each at 600, 750 and 900 mg BID. Once an MTD or a safe-and-biologically-active-dose has been selected as our recommended phase 2 dose, up to 100 patients may be enrolled in an expansion phase. View Clinical Trial