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

NCT07090954 | Not Yet Recruiting Phase 1

• 1 other identifier: GR1803-003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• Dose Escalation: Number of Participants With Dose Limiting Toxicity (DLT)

  The dose limiting toxicities are defined as any of the following events: drug related hematological or non-hematological toxicity of grade 3 or higher.

  Up to 2 Years

• Dose escalation: Number of Participants With Adverse Events and Serious Adverse Events

  Adverse event is any untoward medical occurrence in a clinical trial participants administered a pharmaceutical product, regardless of causal relationship to the study treatment. This includes any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the product. Serious adverse event is an adverse event that results in any of the following outcomes: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, other medically important events.

  Up to 2 Years

• Dose expansion: Overall Response Rate

  The percentage of participants who have a partial response or better according to the International Myeloma Working Group criteria

  Up to 2 Years

Secondary Outcomes (4)

• Duration of Response

  Up to 2 Years

• Progression-Free Survival

  Up to 2 Years

• Serum Concentration of GR1803 Injection

  Up to 2 Years

• Number of Participants With Anti-Drug Antibodies to GR1803 Injection

  Up to 2 Years

Study Arms (1)

GR1803 plus anti-CD38 monoclonal antibody

EXPERIMENTAL

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

Drug: GR1803 injection; Drug: Anti-CD38 Monoclonal Antibody

Interventions

GR1803 injection DRUG

Participants will receive GR1803 injection.

GR1803 plus anti-CD38 monoclonal antibody

Anti-CD38 Monoclonal Antibody DRUG

Participants will receive anti-CD38 monoclonal antibody.

GR1803 plus anti-CD38 monoclonal antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genrix (Shanghai) Biopharmaceutical Co., Ltd.: lead

Study Sites (2)

Shanghai Fourth People's Hospital Affiliated with Tongji University

Shanghai, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Cheng P He, Doctor of Meicine

CONTACT

86+18991232609; hepc_gcp@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 31, 2030
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

CN (2)