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

Myelodysplastic Syndromes Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970822
• Other study ID #: BC3402-104
• Status: Recruiting
• Phase: Phase 1
• Start date: June 18, 2023
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: Biocity Biopharmaceutics Co., Ltd.
• Contact: Zijian Xiao, MD
• Phone: +86 13821085716
• Email: zjxiao[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• BC3402
Escalating of BC3402 will be administered IV(intravenous)
• Azacitidine
Azacitidine will be administered daily

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Biocity Biopharmaceutics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	To evaluate the safety and tolerability of BC3402	2.5 years