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

NCT ID: NCT05970822

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-18
• Study Completion Date: 2025-12-31

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)

Conditions

Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BC3402+azacitidine

Subjects will receive azacitidine and BC3402 in a treatment cycle.

Group Type: EXPERIMENTAL

BC3402

Intervention Type: DRUG

Escalating of BC3402 will be administered IV(intravenous)

Azacitidine

Intervention Type: DRUG

Azacitidine will be administered daily

Interventions

BC3402

Escalating of BC3402 will be administered IV(intravenous)

Intervention Type: DRUG

Azacitidine

Azacitidine will be administered daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocity Biopharmaceutics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhijian Xiao, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zijian Xiao, MD

Role: CONTACT

zjxiao@ihcams.ac.cn

+86 13821085716

Bing Li, MD

Role: CONTACT

libing@ihcams.ac.cn

+86 15522279160

Facility Contacts

Zhijian Xiao, MD

Role: primary

zjxiao@ihcams.ac.cn

+86 13821085716

Other Identifiers

BC3402-104

Identifier Type: -

Identifier Source: org_study_id