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RecruitingNCT05970822Updated Aug 1, 2023

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

A Phase 1 interventional study of BC3402 and Azacitidine in Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia, sponsored by Biocity Biopharmaceutics Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Biocity Biopharmaceutics Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Myelodysplastic Syndromes
  • Chronic Myelomonocytic Leukemia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    BC3402+azacitidine

    Subjects will receive azacitidine and BC3402 in a treatment cycle.

    Drug: BC3402 · Drug: Azacitidine

Interventions

  • DrugBC3402

    Escalating of BC3402 will be administered IV(intravenous)

  • DrugAzacitidine

    Azacitidine will be administered daily

05

What researchers measure

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

    Time frame: 2.5 years

06

Study locations

1 of 1 sites recruiting
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
    Tianjin, Tianjin 300011, China
    Recruiting
07

Registry details

Key details

Study ID
NCT05970822
Lead sponsor
Biocity Biopharmaceutics Co., Ltd.
Responsible party
Sponsor
First posted
Aug 1, 2023
Start date
Jun 18, 2023
Primary completion
Mar 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 1, 2023

Study contacts

Zijian Xiao, MD
Contact
zjxiao@ihcams.ac.cn
+86 13821085716
Bing Li, MD
Contact
libing@ihcams.ac.cn
+86 15522279160
Zhijian Xiao, MD
principal investigator · Institute of Hematology ＆ Blood Diseases Hospital，Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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