Multiple MyelomaPhase 1/2NCT07090954
A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma
A Phase 1/2 study testing GR1803 injection and Anti-CD38 Monoclonal Antibody in people with Multiple Myeloma, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to identify recommended Phase 3 doses (RP3D) for treatment combination (GR1803 injection plus anti-CD38 monoclonal antibody) and to characterize the efficacy of RP3D for the treatment combination. 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 and Anti-CD38 Monoclonal Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesChina
- Study dates
- 31 Aug 2025to 31 Jan 2030
- Phase
- Phase 1/2
- 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
- Eastern Cooperative Oncology Group performance status grade of 0, 1 or 2;
- Diagnosis of multiple myeloma；have received at least one prior line of therapy including Lenalidomide and a proteasome inhibitor.
- Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign informed consent.
Who cannot join
- Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis.
- Active central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Prior treatment with any BCMA-targeted therapiy.
- Active infecion.
- Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Shanghai Fourth People's Hospital Affiliated with Tongji University
Shanghai
Jun W Fu, Doctor of Medicine, 86+13816052522, fuweijun2010@hotmail.com
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Cheng P He, Doctor of Medicine, 86+18991232609, hepc_gcp@163.com
About this study
Official title: An Open-Label, Multicenter, Phase Ib/II Clinical Trial of GR1803 Injection in Combination With an Anti-CD38 Monoclonal Antibody Evaluating Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy in Subjects With Relapsed/Refractory Multiple Myeloma Previously Treated With at Least One Line of Therapy Including Lenalidomide and a Proteasome Inhibitor
The purpose of this study is to identify recommended Phase 3 doses (RP3D) for treatment combination (GR1803 injection plus anti-CD38 monoclonal antibody) and to characterize the efficacy of RP3D for the treatment combination.
- Conditions
- Multiple Myeloma
- Being tested
- GR1803 injection, Anti-CD38 Monoclonal Antibody
- 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 will receive GR1803 injection.
Anti-CD38 Monoclonal AntibodyDrug
Participants will receive anti-CD38 monoclonal antibody.
| Study group | Role | What they receive |
|---|---|---|
| GR1803 plus anti-CD38 monoclonal antibody | Experimental | Participants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection. Receives: Drug: GR1803 injection; Drug: Anti-CD38 Monoclonal Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Number of Participants With Dose Limiting Toxicity (DLT)
The dose limiting toxicities are defined as any of the following events: drug related hematological or non-hematological toxicity of grade 3 or higher.
Measured: Up to 2 Years
Dose escalation: Number of Participants With Adverse Events and Serious Adverse Events
Adverse event is any untoward medical occurrence in a clinical trial participants administered a pharmaceutical product, regardless of causal relationship to the study treatment. This includes any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the product.
Serious adverse event is an adverse event that results in any of the following outcomes: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, other medically important events.
Measured: Up to 2 Years
Dose expansion: Overall Response Rate
The percentage of participants who have a partial response or better according to the International Myeloma Working Group criteria
Measured: Up to 2 Years
Secondary outcomes (4)
Duration of Response
Time from initial partial response or better to progressive disease or death due to any cause
Measured: Up to 2 Years
Progression-Free Survival
Time from first administration of GR1803 injection to tumor progerssion or death from any cause
Measured: Up to 2 Years
Serum Concentration of GR1803 Injection
Serum concentration of GR1803 injection will be assessed
Measured: Up to 2 Years
Number of Participants With Anti-Drug Antibodies to GR1803 Injection
Number of participants with anti-drug antibodies to GR1803 injection will be assessed
Measured: Up to 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start31 Aug 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jan 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT07090954
- Sponsor's protocol ID
- GR1803-003
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase Ib/II Clinical Trial of GR1803 Injection in Combination With an Anti-CD38 Monoclonal Antibody Evaluating Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy in Subjects With Relapsed/Refractory Multiple Myeloma Previously Treated With at Least One Line of Therapy Including Lenalidomide and a Proteasome Inhibitor
- ClinicalTrials.gov ID
- NCT07090954
- Acronym / sponsor ID
- GR1803-003
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 29 Jul 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.
The purpose of this study is to identify recommended Phase 3 doses (RP3D) for treatment combination (GR1803 injection plus anti-CD38 monoclonal antibody) and to characterize the efficacy of RP3D for the treatment combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GR1803 plus anti-CD38 monoclonal antibody | Experimental | Drug: GR1803 injection, Drug: Anti-CD38 Monoclonal AntibodyParticipants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eastern Cooperative Oncology Group performance status grade of 0, 1 or 2;
- Diagnosis of multiple myeloma；have received at least one prior line of therapy including Lenalidomide and a proteasome inhibitor.
- Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign informed consent.
Key exclusion criteria (5 listed)
- Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis.
- Active central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Prior treatment with any BCMA-targeted therapiy.
- Active infecion.
- Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.
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 will receive GR1803 injection. | Drug | GR1803 plus anti-CD38 monoclonal antibody |
| Anti-CD38 Monoclonal AntibodyParticipants will receive anti-CD38 monoclonal antibody. | Drug | GR1803 plus anti-CD38 monoclonal antibody |
Primary outcome
Dose Escalation: Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: Up to 2 Years
The dose limiting toxicities are defined as any of the following events: drug related hematological or non-hematological toxicity of grade 3 or higher.
Dose escalation: Number of Participants With Adverse Events and Serious Adverse Events
Time frame: Up to 2 Years
Adverse event is any untoward medical occurrence in a clinical trial participants administered a pharmaceutical product, regardless of causal relationship to the study treatment. This includes any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the product. Serious adverse event is an adverse event that results in any of the following outcomes: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, other medically important events.
Dose expansion: Overall Response Rate
Time frame: Up to 2 Years
The percentage of participants who have a partial response or better according to the International Myeloma Working Group criteria
4 secondary outcomes
Duration of Response
Time frame: Up to 2 Years
Progression-Free Survival
Time frame: Up to 2 Years
Serum Concentration of GR1803 Injection
Time frame: Up to 2 Years
Number of Participants With Anti-Drug Antibodies to GR1803 Injection
Time frame: Up to 2 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 29 Jul 2025.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
2 sites 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 and Anti-CD38 Monoclonal Antibody in people with Multiple Myeloma, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 2 sites 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Cheng P He, Doctor of Meicine (86+18991232609, hepc_gcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Number of Participants With Dose Limiting Toxicity (DLT) (time frame: Up to 2 Years). The study lists 3 primary outcomes in all. 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 29 Jul 2025.