Multiple MyelomaPhase 3NCT07452198
A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 3 study testing GR1803 injection, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy of GR1803 Injection with daratumumab in combination with pomalidomide and dexamethasone (DPd). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- GR1803 injection, Daratumumab and Pomalidomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2026to Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
Gang An, 13502181109, angang@ihcams.ac.cn
About this study
Official 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
The purpose of this study is to compare the efficacy of GR1803 Injection with daratumumab in combination with pomalidomide and dexamethasone (DPd).
- Conditions
- Multiple Myeloma
- Being tested
- GR1803 injection, Daratumumab, Pomalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR1803 injectionDrug
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.
DaratumumabDrug
Participants received subcutaneous Daratumumab at a dose of 1800 mg.
PomalidomideDrug
Participants received Pomalidomide at a dose of 4 mg on days 1 to 21 of each cycle (28 days).
DexamethasoneDrug
Participants received once-weekly dexamethasone at a dose of 40 mg (≤75 years) or 20 mg (>75 years).
| Study group | Role | What they receive |
|---|---|---|
| Arm A: GR1803 Injection | Experimental | Not described Receives: Drug: GR1803 injection |
| Arm B: DPd | Active comparator | Not described Receives: Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: Up to 5 years
Secondary outcomes (12)
Overall Survival (OS)
Measured: Up to 5 years
Progression Free Survival on Next-line Therapy (PFS2)
Measured: Up to 5 years
Overall Response (Partial Response [PR] or Better)
Measured: Up to 5 years
Complete Response (CR) or Better
Measured: Up to 5 years
Duration of Response
Measured: Up to 5 years
Duration of Complete Response
Measured: Up to 5 years
Time to Response
Measured: Up to 5 years
Minimal Residual Disease (MRD)-negativity
Measured: Up to 5 years
Number of Participants with Adverse Events (AEs) by Severity
Measured: Up to 5 years
Serum Concentration of GR1803 Injection
Measured: Up to 5 years
Number of Participants with Anti-drug Antibodies (ADAs) to GR1803 Injection
Measured: Up to 5 years
Change from Baseline in Overall Health-related Quality of Life as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
The EQ-5D-5L ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start9 Mar 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Genrix (Shanghai) Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452198
- Sponsor's protocol ID
- GR1803-004
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07452198
- Acronym / sponsor ID
- GR1803-004
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of GR1803 Injection with daratumumab in combination with pomalidomide and dexamethasone (DPd).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: GR1803 Injection | Experimental | Drug: GR1803 injection |
| Arm B: DPd | Active comparator | Drug: Daratumumab, Drug: Pomalidomide, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GR1803 injectionParticipants 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. | Drug | Arm A: GR1803 Injection |
| DaratumumabParticipants received subcutaneous Daratumumab at a dose of 1800 mg. | Drug | Arm B: DPd |
| PomalidomideParticipants received Pomalidomide at a dose of 4 mg on days 1 to 21 of each cycle (28 days). | Drug | Arm B: DPd |
| DexamethasoneParticipants received once-weekly dexamethasone at a dose of 40 mg (≤75 years) or 20 mg (>75 years). | Drug | Arm B: DPd |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to 5 years
12 secondary outcomes
Overall Survival (OS)
Time frame: Up to 5 years
Progression Free Survival on Next-line Therapy (PFS2)
Time frame: Up to 5 years
Overall Response (Partial Response [PR] or Better)
Time frame: Up to 5 years
Complete Response (CR) or Better
Time frame: Up to 5 years
Duration of Response
Time frame: Up to 5 years
Duration of Complete Response
Time frame: Up to 5 years
Time to Response
Time frame: Up to 5 years
Minimal Residual Disease (MRD)-negativity
Time frame: Up to 5 years
Number of Participants with Adverse Events (AEs) by Severity
Time frame: Up to 5 years
Serum Concentration of GR1803 Injection
Time frame: Up to 5 years
Number of Participants with Anti-drug Antibodies (ADAs) to GR1803 Injection
Time frame: Up to 5 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GR1803 injection, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang An (13502181109, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.