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

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)

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 Overview

• Status: Recruiting
• Conditions: Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia
• Intervention / Treatment: Drug: BC3402; Drug: Azacitidine

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zijian Xiao, MD; Phone Number: +86 13821085716; Email: zjxiao@ihcams.ac.cn
• Study Contact Backup: Name: Bing Li, MD; Phone Number: +86 15522279160; Email: libing@ihcams.ac.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300011
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
      • Contact: Zhijian Xiao, MD; Phone Number: +86 13821085716; Email: zjxiao@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BC3402+azacitidine; Subjects will receive azacitidine and BC3402 in a treatment cycle.	Drug: BC3402; Escalating of BC3402 will be administered IV(intravenous); Drug: Azacitidine; Azacitidine will be administered daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biocity Biopharmaceutics Co., Ltd.
• Investigators: Principal Investigator: Zhijian Xiao, MD, Institute of Hematology ＆ Blood Diseases Hospital，Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myeloid; Chronic Disease; Myelodysplastic Syndromes; Leukemia; Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Azacitidine
• Other Study ID Numbers: BC3402-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No