Study Evaluating the Efficacy and Safety of CM336 Injecti... | NCT07039578

Studies
Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis

NCT07039578

Sponsor

Keymed Biosciences Co.Ltd

Status

Recruiting

Last Update Posted

Nov 26, 2025Actual

Enrollment

90Estimated

Phase

Phase 2

Conditions

Primary Light-Chain Amyloidosis

Interventions

CM336 Injection(Low dose group)
CM336 Injection(High dose group)

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

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2025Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jul 31, 2029Estimated

First Submitted Date

Jun 18, 2025

First Submission Date that Met QC Criteria

Jun 18, 2025

First Posted Date

Jun 26, 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

Nov 20, 2025

Last Update Posted Date

Nov 26, 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

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low dose group(CM336)	Experimental		Biological: CM336 Injection(Low dose group)
High dose group(CM336)	Experimental		Biological: CM336 Injection(High dose group)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CM336 Injection(Low dose group)	Biological	subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.	Low dose group(CM336)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the efficacy after CM336 treatment	Hematologic complete response (hCR) rate	up to 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntary provision of written informed consent and ability to comply with protocol requirements.
Age ≥18 years, any gender.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
Confirmed diagnosis of primary light-chain (AL) amyloidosis.
Relapsed or refractory primary AL amyloidosis.
Measurable hematologic disease at screening (per protocol-defined criteria).
Involvement of ≥1 amyloid-affected organ.
Adequate organ function meeting all protocol-specified criteria within 3 days prior to first dose.

Exclusion Criteria:

Current or prior diagnosis of multiple myeloma.
Received anti-AL amyloidosis therapy within protocol-specified timeframe prior to first dose.
Clinically significant cardiovascular or cerebrovascular disease.
Any active or uncontrolled infection meeting protocol-defined criteria.
Any other condition deemed by the Investigator to preclude safe study participation.

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
Jian Li	Peking Union Medical College Hospital	Principal Investigator
Gang An	Institute of Hematology & Blood Diseases Hospital, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality		China

ID	Term
D003710	Demography
D011154	Population Characteristics