A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma

NCT ID: NCT07090954

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2030-01-31

Brief Summary

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The purpose of this study is to identify recommended Phase 3 doses (RP3D) for treatment combination (GR1803 injection plus anti-CD38 monoclonal antibody) and to characterize the efficacy of RP3D for the treatment combination.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GR1803 plus anti-CD38 monoclonal antibody

Participants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection.

Group Type EXPERIMENTAL

GR1803 injection

Intervention Type DRUG

Participants will receive GR1803 injection.

Anti-CD38 Monoclonal Antibody

Intervention Type DRUG

Participants will receive anti-CD38 monoclonal antibody.

Interventions

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GR1803 injection

Participants will receive GR1803 injection.

Intervention Type DRUG

Anti-CD38 Monoclonal Antibody

Participants will receive anti-CD38 monoclonal antibody.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Eastern Cooperative Oncology Group performance status grade of 0, 1 or 2;
* Diagnosis of multiple myeloma;have received at least one prior line of therapy including Lenalidomide and a proteasome inhibitor.
* Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign informed consent.

Exclusion Criteria

* Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis.
* Active central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
* Prior treatment with any BCMA-targeted therapiy.
* Active infecion.
* Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genrix (Shanghai) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Fourth People's Hospital Affiliated with Tongji University

Shanghai, , China

Site Status

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status

Countries

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China

Central Contacts

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Cheng P He, Doctor of Meicine

Role: CONTACT

86+18991232609

Facility Contacts

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Jun W Fu, Doctor of Medicine

Role: primary

86+13816052522

Cheng P He, Doctor of Medicine

Role: primary

86+18991232609

Other Identifiers

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GR1803-003

Identifier Type: -

Identifier Source: org_study_id

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