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GR1803 Injection in Patients With RRMM
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-04-24
Completion Date
2027-12-01
Last Updated
2025-04-30
Healthy Volunteers
No
Conditions
Interventions
GR1803
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