RecruitingPhase 2NCT06566547

GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma

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

Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Enrollment

116 participants

Start Date

Aug 26, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

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 GR1803 — a new BCMA-targeting injection — in patients with relapsed or refractory multiple myeloma (a blood cancer affecting plasma cells in the bone marrow) that has come back or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older with a diagnosis of multiple myeloma - Your disease has relapsed (come back) or is not responding to current therapy - Your myeloma is measurable by blood or urine markers - Your general health score (ECOG) is 0–2 **You may NOT be eligible if...** - You have previously been treated with any BCMA-targeting therapy (such as belantamab mafodotin or BCMA CAR-T therapy) - Your myeloma has spread to the brain or spinal fluid - You have plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloidosis - You have known allergy or intolerance to teclistamab or similar drugs 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 injection

D1 given at a dose of 30ug/kg, D4 given at a dose of 90ug/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