Study of BC3402 in Combination With Azacitidine in Patients With MDS and CMML

A Phase 1b Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of BC3402 in Combination With Azacitidine in Subjects With Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML)

The study is to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of BC3402 in combination with azacitidine (AZA) in subjects with Myelodysplastic Syndrome (MDS) and Chronic myelomonocytic leukemia (CMML)

Inclusion Criteria:

1. MDS and CMML subjects with higher risk;
2. Age ≥ 18 years old;
3. Eastern Cooperative Oncology Group score of 0~2;
4. Not suitable for or refuse to receive hematopoietic stem cell transplant(HSCT);
5. Subjects should take effective contraceptive measures
6. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.

Exclusion Criteria:

1. Prior exposure to anti-TIM-3 therapy at any time
2. Previous HSCT
3. Live vaccine administered within 4 weeks prior to start of treatment
4. Current use or use within 7 days prior to start of treatment of systemic steroid therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed.

Other protocol-defined Inclusion/Exclusion may apply.