RecruitingPhase 2NCT06952075

GR1803 Injection in Patients With RRMM

Single-Arm, Open, Multi-Center Phase II Clinical Trial of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma Complicated by Extramedullary Plasmacytoma


Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Enrollment

30 participants

Start Date

Apr 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called GR1803 (a bispecific antibody targeting BCMA and CD3) in patients with relapsed or refractory multiple myeloma (a type of bone marrow cancer) that has also developed tumors outside the bone marrow (extramedullary plasmacytoma). The goal is to evaluate safety and effectiveness of this targeted therapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with multiple myeloma that has also formed tumors outside the bone marrow (extramedullary plasmacytoma) - Your disease has relapsed or is no longer responding to treatment - You are in reasonable overall health (ECOG score 0-2) **You may NOT be eligible if...** - You have previously received any therapy specifically targeting BCMA - Your multiple myeloma has spread to the brain or spinal fluid (active CNS involvement) - You have a known allergy or intolerance to teclistamab or its ingredients - You have plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloidosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGR1803

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


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

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NCT06952075


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