NCT05970822RecruitingPhase 1
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)
Biocity Biopharmaceutics Co., Ltd.1 site in 1 country32 target enrollmentStarted: June 18, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •MDS and CMML subjects with higher risk;
- •Age ≥ 18 years old;
- •Eastern Cooperative Oncology Group score of 0~2;
- •Not suitable for or refuse to receive hematopoietic stem cell transplant(HSCT);
- •Subjects should take effective contraceptive measures
- •Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
Exclusion Criteria
- •Prior exposure to anti-TIM-3 therapy at any time
- •Previous HSCT
- •Live vaccine administered within 4 weeks prior to start of treatment
- •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.
Arms & Interventions
BC3402+azacitidine
Experimental
Subjects will receive azacitidine and BC3402 in a treatment cycle.
Intervention: BC3402 (Drug)
BC3402+azacitidine
Experimental
Subjects will receive azacitidine and BC3402 in a treatment cycle.
Intervention: Azacitidine (Drug)
Outcomes
Primary Outcomes
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)
Time Frame: 2.5 years
To evaluate the safety and tolerability of BC3402
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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