Study of CM313(SC) Injection in Subjects With Relapsed/Re... | NCT06791824

Studies
Study of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia

NCT06791824

Sponsor

Keymed Biosciences Co.Ltd

Status

Not yet recruiting

Last Update Posted

Feb 18, 2025Actual

Enrollment

125Estimated

Phase

Phase 1Phase 2

Conditions

Aplastic Anemia

Interventions

CM313(SC) injection
CM313(SC) injection
CM313(SC) injection

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

Feb 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2025Estimated

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Jan 15, 2025

First Submission Date that Met QC Criteria

Jan 19, 2025

First Posted Date

Jan 24, 2025Actual

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

Feb 14, 2025

Last Update Posted Date

Feb 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This is a randomized, open-label, phase IB/II clinical study to evaluate the safety, tolerability and preliminary efficacy of CM313(SC) injection in patients with relapsed/refractory aplastic anemia

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
CM313(SC)(low dose group)	Experimental	Biological: CM313(SC) injection
CM313(SC)(medium dose group)	Experimental	Biological: CM313(SC) injection
CM313(SC)(high dose group)	Experimental	Biological: CM313(SC) injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CM313(SC) injection	Biological	Phase IB: CM313(SC) administered at low dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events (AE)	Assess the safety and tolerability	Up to 52 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of idiopathic aplastic anemia.
Patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol.
Male or female, age≥18 years.
The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.
Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

The inherited bone marrow failure syndromes.
Previously treated with the anti-CD38 monoclonal antibody.
Have an allergy to humanized monoclonal antibody or any part of CM313.
Pregnant or breastfeeding females, or females planning to become pregnant during the study.
Any condition considered to be ineligible for the study by the investigator.

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
Qian Jia	Contact	028-88610620		qianjia@keymedbio.com

Overall Officials

Name	Affiliation	Role
Jun Shi	Institute of Hematology & Blood Diseases Hospital, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Hematology & Blood Diseases Hospital		Tianjin	Tianjin Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D000741	Anemia, Aplastic

Ancestor Terms

ID	Term
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000080983	Bone Marrow Failure Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007267	Injections

Ancestor Terms

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided