Evaluating BC3402 with Azacitidine for Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia
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)
This study is testing if a new drug called BC3402, when used with azacitidine, can help people with higher-risk Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia who can't have a stem cell transplant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biocity Biopharmaceutics Co., Ltd. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05970822 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, pharmacokinetics, pharmacodynamics, and efficacy of BC3402 in combination with azacitidine in patients diagnosed with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML). It aims to determine how well this combination therapy works in higher-risk patients who are not suitable for hematopoietic stem cell transplant. Participants will be monitored for their response to treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with higher-risk MDS or CMML who are not candidates for hematopoietic stem cell transplant.
Not a fit: Patients who have previously received anti-TIM-3 therapy or hematopoietic stem cell transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with MDS and CMML, potentially improving their outcomes.
How similar studies have performed: While this approach is novel, similar studies evaluating combination therapies for MDS and CMML have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin, Tianjin
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Zhijian Xiao, MD — Institute of Hematology ＆ Blood Diseases Hospital，Chinese Academy of Medical Sciences
- Study coordinator: Zijian Xiao, MD
- Email: zjxiao@ihcams.ac.cn
- Phone: +86 13821085716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.