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NCT07452198RecruitingPhase 3

A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3, Multicenter, Open-Label, Randomized Study Comparing GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy Including Lenalidomide and Proteasome Inhibitors

Source: ClinicalTrials.gov · Last updated 25 Mar 2026

Brief summary (registry, in English)

The purpose of this study is to compare the efficacy of GR1803 Injection with daratumumab in combination with pomalidomide and dexamethasone (DPd).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
358 (estimated)
First submitted
28 Feb 2026
Start date
9 Mar 2026
Primary completion date
Mar 2029
Lead sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
NCT number
NCT07452198

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 358
  • From 9 Mar 2026 to the primary completion date, Mar 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received any prior B cell maturation antigen (BCMA)-directed therapy.
  • Prior antitumor therapy, within 21 days (PI 、IMiDs or radiotherapy within 14 days, clinical trial vaccine within 28 days, Gene modified adoptive cell therapy within 3 months, allogeneic stem cell transplantation within 6 months, autologous stem cell transplantation within 12 weeks) prior to first dose of study drug.
  • Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within 14 days prior to first dose of study drug.
  • Active malignancies other than relapsed/refractory multiple myeloma within 3 years prior to screening.
  • Received a live, attenuated vaccine within 4 weeks before first dose of study drug.
  • Have major surgery within 2 weeks before first dose of study drug.

Other illness

  • Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or amyloidosis (including primary and secondary).
  • Has disease that is considered refractory or intolerant to an anti-cluster of differentiation 38 (CD38) targeted therapy or Pomalidomide.
  • History of Guillain Barre Syndrome (GBS) or variant GBS.
  • The following medical conditions: active infecion, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, Syphilis infection, thromboembolic events or cerebrovascular events less than or equal to (\<=) 6 m, seizure attacks less than or equal to (\<=) 6 m.
  • Active autoimmune disease or history of autoimmune disease.
  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.

Other

  • History or clinical signs of central nervous system involvement or meningeal involvement of multiple myeloma .
  • Grade \>= 2 peripheral neuropathy at screening.
  • Pregnant, lactating female.

Who the study is looking for

  • Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and baseline.
  • Diagnosed as multiple myeloma according to the diagnostic criteria of the International Myeloma Working Group (IMWG) diagnostic criteria.
  • Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion.
  • Documented evidence of progressive or stable disease based on investigator's determination of response by IMWG criteria on or after their last regimen.
  • Measurable disease at screening and baseline as defined by any of the following: 1) serum M-protein level greater than or equal to (\>=) 5 gram per liter (g/L); or 2) urine M-protein level \>=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain \>=100 mg/L and abnormal serum immunoglobulin kappa lambda free light chain ratio.
  • Have clinical laboratory values within the specified range.
  • Have an understanding of and comply with the clinical trial protocol requirements, voluntarily participate in the clinical trial, and sign the informed consent form.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
TianjinChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.