Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes
Conditions
Brief summary
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)
Interventions
DRUGBC3402
Escalating of BC3402 will be administered IV(intravenous)
DRUGAzacitidine
Azacitidine will be administered daily
Sponsors
Biocity Biopharmaceutics Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with AEs and SAEs Primary endpoint:Incidence of dose limiting toxiecities(DLTs) and incidence of DLT events within 28 days (first cycle) | 2.5 years | To evaluate the safety and tolerability of BC3402 |
Countries
China
Contacts
Primary ContactZijian Xiao, MD
Backup ContactBing Li, MD
Outcome results
None listed