A Phase 1b Dose Escalation and Dose Expansion Study of CLN 049 in Combination With Azacitidine and Venetoclax for the Treatment of Adult Patients With Newly Diagnosed, Acute Myeloid Leukemia
Cullinan Therapeutics Inc.
Summary
A Phase 1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously (IV) administered CLN-049 in combination with azacitidine (Aza) and venetoclax (Ven) in patients with newly diagnosed (ND) AML.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients aged ≥ 18 years of age with newly diagnosed, previously untreated AML (including MDS/AML) 2. Patients are not candidates for intensive induction chemotherapy because they are either unfit or otherwise clinically unsuitable for anthracycline/ cytarabine-based induction therapy 3. White blood cell (WBC) count at the time of C1D1 ≤ 20,000/μL 4. Patients must have previously untreated AML; hydroxyurea for cytoreduction is permitted up to C1D1. Prior therapy for MDS is allowed except for hypomethylating agents and venetoclax. 5. Eastern Cooperative Oncology Group (E…
Interventions
- DrugCLN-049
CLN-049 will be initiated using two step-up doses (SUDs), followed by the first target dose (TD) one week later, and weekly thereafter.
- DrugAzacitidine
Azacitidine 75 mg/m2 will initially be administered sub-cutaneous or intravenous on days 1 through 7 of a 28-day cycle
- DrugVenetoclax
Venetoclax will initially be administered orally on days 1 through 28 of a 28-day cycle and then reduced to days 1 through 14 in consolidation cycles.
Locations (3)
- City of HopeDuarte, California
- New York University Langone HealthNew York, New York
- MD AndersonHouston, Texas