Study of BC3402 in Combination With Azacitidine in Patien... | NCT05970822

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

NCT05970822

Sponsor

Biocity Biopharmaceutics Co., Ltd.

Status

Unknown status

Last Update Posted

Aug 1, 2023Actual

Enrollment

32Estimated

Phase

Phase 1

Conditions

Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia

Interventions

BC3402
Azacitidine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2023Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Jul 13, 2023

First Submission Date that Met QC Criteria

Jul 30, 2023

First Posted Date

Aug 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2023

Last Update Posted Date

Aug 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BC3402+azacitidine	Experimental	Subjects will receive azacitidine and BC3402 in a treatment cycle.	Drug: BC3402 Drug: Azacitidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BC3402	Drug	Escalating of BC3402 will be administered IV(intravenous)	BC3402+azacitidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	2.5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zijian Xiao, MD	Contact	+86 13821085716		zjxiao@ihcams.ac.cn
Bing Li, MD	Contact	+86 15522279160		libing@ihcams.ac.cn

Overall Officials

Name	Affiliation	Role
Zhijian Xiao, MD	Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences	Recruiting	Tianjin	Tianjin Municipality	300011	China

Condition Browse Module

MeSH Terms

ID	Term
D009190	Myelodysplastic Syndromes
D015477	Leukemia, Myelomonocytic, Chronic

Ancestor Terms

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007951	Leukemia, Myeloid

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001374	Azacitidine

Ancestor Terms

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided