Multiple Myeloma (MM)Phase 1/2NCT07102706
Phase I Trial of GR1803 Injection in Patients With RRMM
A Phase 1/2 study testing GR1803 injection in people with Multiple Myeloma (MM), run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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 52 weeks or until the subject… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- GR1803 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2022to 20 May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- ECOG score 0-2.
- ≥18 years of age.
- Multiple myeloma must be measurable by central laboratory assessment:
- Serum monoclonal paraprotein (M-protein) level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
- Light chain multiple myeloma without measurable disease in the serum or the urine:
- Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
Who cannot join
- Prior treatment with any BCMA-targeted therapy.
- Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
About this study
Official title: A Phase I Monotherapy Study Assessing the Safety and Efficacy of GR1803, a BCMA×CD3 Bispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma
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 52 weeks or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- GR1803 injection
- 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
weekly dose up to week 24 , biweekly dose from week 24 to week 36, and triweekly dose from week 36 to week 52
| Study group | Role | What they receive |
|---|---|---|
| 0.02ug/kg GR1803 | Experimental | Not described Receives: Drug: GR1803 injection |
| 1ug/kg GR1803 | Experimental | Not described Receives: Drug: GR1803 injection |
| 10ug/kg GR1803 | Experimental | Not described Receives: Drug: GR1803 injection |
| 30ug/kg GR1803 | Experimental | Not described Receives: Drug: GR1803 injection |
| 90ug/kg GR1803 | Experimental | Not described Receives: Drug: GR1803 injection |
| 180ug/kg GR1803 | Experimental | Not described Receives: Drug: GR1803 injection |
| 240ug/kg GR1803 | Experimental | Not described Receives: Drug: GR1803 injection |
| 300ug/kg GR1803 | Experimental | Not described Receives: Drug: GR1803 injection |
| 360ug/kg GR1803 | Experimental | Not described Receives: Drug: GR1803 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose Limited Toxicity
Measured: 52 weeks
Secondary outcomes (2)
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)
Measured: 52 weeks
Progression-free survival (PFS)
Time from enrollment to tumor progression or death from any cause
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start27 May 2022
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Jin, PhD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102706
- Sponsor's protocol ID
- GR1803-001
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Monotherapy Study Assessing the Safety and Efficacy of GR1803, a BCMA×CD3 Bispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07102706
- Acronym / sponsor ID
- GR1803-001
- Conditions
- Multiple Myeloma (MM)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 May 2022 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 5 Aug 2025 (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.
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 52 weeks or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 0.02ug/kg GR1803 | Experimental | Drug: GR1803 injection |
| 1ug/kg GR1803 | Experimental | Drug: GR1803 injection |
| 10ug/kg GR1803 | Experimental | Drug: GR1803 injection |
| 30ug/kg GR1803 | Experimental | Drug: GR1803 injection |
| 90ug/kg GR1803 | Experimental | Drug: GR1803 injection |
| 180ug/kg GR1803 | Experimental | Drug: GR1803 injection |
| 240ug/kg GR1803 | Experimental | Drug: GR1803 injection |
| 300ug/kg GR1803 | Experimental | Drug: GR1803 injection |
| 360ug/kg GR1803 | Experimental | Drug: GR1803 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG score 0-2.
- ≥18 years of age.
- Multiple myeloma must be measurable by central laboratory assessment:
- Serum monoclonal paraprotein (M-protein) level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
- Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
Key exclusion criteria (3 listed)
- Prior treatment with any BCMA-targeted therapy.
- Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
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 injectionweekly dose up to week 24 , biweekly dose from week 24 to week 36, and triweekly dose from week 36 to week 52 | Drug | 0.02ug/kg GR1803, 10ug/kg GR1803, 180ug/kg GR1803, 1ug/kg GR1803, 240ug/kg GR1803, 300ug/kg GR1803, 30ug/kg GR1803, 360ug/kg GR1803, 90ug/kg GR1803 |
Primary outcome
DLT
Time frame: 52 weeks
Dose Limited Toxicity
2 secondary outcomes
ORR
Time frame: 52 weeks
Progression-free survival (PFS)
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No. Study Protocol
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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. This study is not recruiting at the moment.
Jie Jin, PhD principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GR1803 injection in people with Multiple Myeloma (MM), 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 5 Aug 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 52 weeks). 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 5 Aug 2025.