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NCT Number: NCT07452198

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or amyloidosis (including primary and secondary).
  • History or clinical signs of central nervous system involvement or meningeal involvement of multiple myeloma .
  • Received any prior B cell maturation antigen (BCMA)-directed therapy.
  • Has disease that is considered refractory or intolerant to an anti-cluster of differentiation 38 (CD38) targeted therapy or Pomalidomide.
  • 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.
  • Grade >= 2 peripheral neuropathy at screening.
  • 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 malignancies other than relapsed/refractory multiple myeloma within 3 years prior to screening.
  • Active autoimmune disease or history of autoimmune disease.
  • 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.
  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
  • Pregnant, lactating female.

Treatment and study plan

GR1803 injection

Drug

Participants received intravenous GR1803 injection at a dose of 180 ug per kilogram, which had been preceded by step-up doses of 10 and 30 ug per kilogram.

Daratumumab

Drug

Participants received subcutaneous Daratumumab at a dose of 1800 mg.

Pomalidomide

Drug

Participants received Pomalidomide at a dose of 4 mg on days 1 to 21 of each cycle (28 days).

Dexamethasone

Drug

Participants received once-weekly dexamethasone at a dose of 40 mg (≤75 years) or 20 mg (>75 years).

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Up to 5 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 5 years

  2. Progression Free Survival on Next-line Therapy (PFS2)

    Time frame: Up to 5 years

  3. Overall Response (Partial Response [PR] or Better)

    Time frame: Up to 5 years

  4. Complete Response (CR) or Better

    Time frame: Up to 5 years

  5. Duration of Response

    Time frame: Up to 5 years

  6. Duration of Complete Response

    Time frame: Up to 5 years

  7. Time to Response

    Time frame: Up to 5 years

  8. Minimal Residual Disease (MRD)-negativity

    Time frame: Up to 5 years

  9. Number of Participants with Adverse Events (AEs) by Severity

    Time frame: Up to 5 years

  10. Serum Concentration of GR1803 Injection

    Time frame: Up to 5 years

  11. Number of Participants with Anti-drug Antibodies (ADAs) to GR1803 Injection

    Time frame: Up to 5 years

  12. Change from Baseline in Overall Health-related Quality of Life as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)

    Time frame: Up to 5 years

    The EQ-5D-5L ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Mar 5, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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