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

Phase 1

Recruiting

• Conditions: Chronic Myelomonocytic Leukemia; Myelodysplastic Syndromes
• Interventions: Drug: BC3402; Drug: Azacitidine

• Registration Number: NCT05970822
• Lead Sponsor: Biocity Biopharmaceutics Co., Ltd.

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-18
• Status Verified: 2023-07
• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-30
• Last Update Submitted: 2023-07-30
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01
• Primary Completion: 2025-03
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BC3402+azacitidine	BC3402	Subjects will receive azacitidine and BC3402 in a treatment cycle.
BC3402+azacitidine	Azacitidine	Subjects will receive azacitidine and BC3402 in a treatment cycle.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, Tianjin, China