Clinical trial · Interventional
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)
NCT05970822CI-TRIAL-00068425unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| BC3402 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BC3402+azacitidine
- description
- Subjects will receive azacitidine and BC3402 in a treatment cycle.
- interventionNames
- Drug: BC3402
- Drug: Azacitidine
Primary outcomes (1)
- measure
- 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)
- timeFrame
- 2.5 years
- description
- To evaluate the safety and tolerability of BC3402
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.