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

Genrix (Shanghai) Biopharmaceutical

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: GR1803 injection

Drug: Anti-CD38 Monoclonal Antibody

Study type

Interventional

Funder types

Industry

Identifiers

NCT07090954

GR1803-003

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.