About this trial

This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 (docirbrutinib) in patients with CLL/SLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.

Eligibility criteria

Qualifiers

Age ≥18 years

Provided written informed consent

Histologically confirmed B-cell malignancy, including CLL/SLL, WM, MCL, MZL, or FL

Patients with SLL, MCL, MZL, and FL: at least 1 radiographically measurable lesion

Disqualifiers

Transformed disease (eg, Richter's transformation) prior to or during Screening

Investigational agent or anticancer therapy within 5 half-lives before the planned start of docirbrutinib, except therapeutic monoclonal antibody treatment which must be discontinued at least 4 weeks before the start of docirbrutinib

Current treatment with investigational therapy or planned investigational therapy which would be concurrent with this study

Requiring therapeutic anticoagulation with warfarin

Trial design

Treatments tested in this trial

  • Docirbrutinib

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

13
California
UC Irvine Health92868, Orange United States
Florida
Mount Sinai Comprehensive Cancer Center33140, Miami Beach United States
Moffitt Cancer Center33612, Tampa United States
Illinois
Northwestern Memorial Hospital60661, Chicago United States

Sponsors and collaborators

Carna Biosciences, Inc.

Lead sponsor