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

Sponsor

Biocity Biopharmaceutics Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05970822

Collaborator

(none)

Enrollment

Location

Arm

29.5

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia	Drug: BC3402 Drug: Azacitidine	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Jun 18, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BC3402+azacitidine Subjects will receive azacitidine and BC3402 in a treatment cycle.	Drug: BC3402 Escalating of BC3402 will be administered IV(intravenous) Drug: Azacitidine Azacitidine will be administered daily

Arm

Intervention/Treatment

Experimental: BC3402+azacitidine

Subjects will receive azacitidine and BC3402 in a treatment cycle.

Drug: BC3402

Escalating of BC3402 will be administered IV(intravenous)

Drug: Azacitidine

Azacitidine will be administered daily

Outcome Measures

Primary Outcome Measures

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) [2.5 years]
To evaluate the safety and tolerability of BC3402

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Other protocol-defined Inclusion/Exclusion may apply.