Phase I Trial of GR1803 Injection in Patients With RRMM

NCT07102706 | Completed Phase 1

• 1 other identifier: GR1803-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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 52 weeks or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.

Conditions

Multiple Myeloma (MM)

Outcome Measures

Primary Outcomes (1)

• DLT

  Dose Limited Toxicity

  52 weeks

Secondary Outcomes (2)

• ORR

  52 weeks

• Progression-free survival (PFS)

  52 weeks

Study Arms (9)

0.02ug/kg GR1803

EXPERIMENTAL

Drug: GR1803 injection

1ug/kg GR1803

EXPERIMENTAL

Drug: GR1803 injection

10ug/kg GR1803

EXPERIMENTAL

Drug: GR1803 injection

30ug/kg GR1803

EXPERIMENTAL

Drug: GR1803 injection

90ug/kg GR1803

EXPERIMENTAL

Drug: GR1803 injection

180ug/kg GR1803

EXPERIMENTAL

Drug: GR1803 injection

240ug/kg GR1803

EXPERIMENTAL

Drug: GR1803 injection

300ug/kg GR1803

EXPERIMENTAL

Drug: GR1803 injection

360ug/kg GR1803

EXPERIMENTAL

Drug: GR1803 injection

Interventions

GR1803 injection DRUG

weekly dose up to week 24 , biweekly dose from week 24 to week 36, and triweekly dose from week 36 to week 52

0.02ug/kg GR1803; 10ug/kg GR1803; 180ug/kg GR1803; 1ug/kg GR1803; 240ug/kg GR1803; 300ug/kg GR1803; 30ug/kg GR1803; 360ug/kg GR1803; 90ug/kg GR1803

Eligibility Criteria

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

You may qualify if:

• ECOG score 0-2.
• ≥18 years of age.
• Multiple myeloma must be measurable by central laboratory assessment:
• Serum monoclonal paraprotein (M-protein) level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
• Light chain multiple myeloma without measurable disease in the serum or the urine:
• Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.

You may not qualify if:

• Prior treatment with any BCMA-targeted therapy.
• Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
• Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Multiple Myeloma

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

Study Officials

• Jie Jin, PhD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 5, 2025
• Study Start: May 27, 2022
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)