A Phase 2 interventional study of GR1803 in Multiple Myleoma, sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd. (part of Chongqing Genrix Biopharmaceutical Co., Ltd) · Phase 2, Interventional, and Treatment
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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.
Genrix (Shanghai) Biopharmaceutical Co., Ltd. is the lead sponsor of 28 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: 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
ORR
Sum of the proportions of patients with proven strict complete remission (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR)
Time frame: 2 years
Progression-free survival (PFS)
Time from enrollment to tumor progression or death from any cause
Time frame: 2 years
AE
adverse event
Time frame: 2 years
Plan to share: No — Study Protocol
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Jul 2027, 26 months after the start.
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Studies of the drug tested here: GR1803
Genrix (Shanghai) Biopharmaceutical Co., Ltd. →