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

Biocity Biopharmaceutics

Status and phase: Enrolling; Phase 1

Conditions: Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia

Treatments: Drug: BC3402; Drug: Azacitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05970822

BC3402-104

Details and patient eligibility

About

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)

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

BC3402+azacitidine

Experimental group

Description:

Subjects will receive azacitidine and BC3402 in a treatment cycle.

Treatment:

Drug: Azacitidine

Drug: BC3402