GR1803 Injection in Patients With RRMM | NCT06952075

Studies
GR1803 Injection in Patients With RRMM

NCT06952075

Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Apr 30, 2025Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Multiple Myleoma

Interventions

GR1803

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

Apr 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

Apr 24, 2025Actual

Primary Completion Date

Jul 1, 2027Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Apr 23, 2025

First Submission Date that Met QC Criteria

Apr 23, 2025

First Posted Date

Apr 30, 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

Apr 23, 2025

Last Update Posted Date

Apr 30, 2025Actual

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

All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GR1803	Experimental		Drug: GR1803

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GR1803	Drug	D1 given at a dose of 10ug/kg, D4 given at a dose of 30ug/kg, D8 given at a dose of 180ug/kg, followed by weekly dosing up to cycle 9, and cycle 10 and onwards, every 2 weeks, with a dosing cycle of every 4 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ORR	Sum of the proportions of patients with proven strict complete remission (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR)	2 years

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)	Time from enrollment to tumor progression or death from any cause	2 years
AE	adverse event	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1、ECOG score 0-2 2、≥18 years of age 3、Multiple myeloma must be Complicated by Extramedullary Plasmacytoma.

Exclusion Criteria:

1、Prior treatment with any BCMA-targeted therapy 2、Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma 3、Known allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its excipients 4、Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.

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
Gang An, PhD	Contact	+8613502181109		angang@ihcams.ac.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Hematology & Blood Diseases Hospital	Recruiting	Tianjin	Tianjin Municipality	250033	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Study Protocol

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided