Carna Biosciences, Inc.
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.
This study consists of 2 parts. Dose escalation part will enroll up to 27 patients to evaluate safety profile and tolerance of docirbrutinib using 3+3 design. The starting dose of docirbrutinib in oral tablet form is 100 mg twice daily (200 mg/day). Dose escalation will continue up to the planned maximum dose level or until the maximum tolerated dose (MTD) has been identified. Dose expansion part will enroll up to 48 CLL/SLL patients (Cohort 1), up to 35 NHL patients (Cohort 2), and up to 10 patients with prior pirtobrutinib treatment for an approved indication (Cohort 3). The first 30 patie…
Inclusion Criteria: * 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 * Failed or are intolerant to ≥2 prior lines of systemic therapy * ECOG Performance Status 0 to 2 * Adequate hematologic status (ie, absolute neutrophil count ≥0.75 × 10⁹/L, platelet count ≥50 × 10⁹/L, hemoglobin ≥8 g/dL) not requiring transfusion support or growth factors * Adequate hepatic function * Adequate renal function * Ability to swallow tablets…
oral tablet, twice daily