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

NCT05970822 | Unknown Phase 1

• 1 other identifier: BC3402-104
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

BC3402+azacitidine

EXPERIMENTAL

Subjects will receive azacitidine and BC3402 in a treatment cycle.

Drug: BC3402; Drug: Azacitidine

Interventions

BC3402 DRUG

Escalating of BC3402 will be administered IV(intravenous)

BC3402+azacitidine

Azacitidine DRUG

Azacitidine will be administered daily

BC3402+azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocity Biopharmaceutics Co., Ltd.: lead

Study Sites (1)

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

Tianjin, Tianjin Municipality, 300011, China

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Zhijian Xiao, MD

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zijian Xiao, MD

CONTACT

+86 13821085716; zjxiao@ihcams.ac.cn

Bing Li, MD

CONTACT

+86 15522279160; libing@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 1, 2023
• Study Start: June 18, 2023
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CN (1)