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Multiple MyelomaPhase 2NCT07764861

A Open-Label Phase in Participants With Multiple Myeloma

A Phase 2 study testing Dexamethasone, IBI3003 and Lenalidomide in people with Multiple Myeloma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is an open-label, multi-center phase II study of IBI3003 in combination with anti-CD38 monoclonal antibody in adult subjects with multiple myeloma. This study includes a safety run-in period and 2 cohorts (Cohorts 1 and 2).In the safety run-in period, subjects with measurable relapsed or refractory multiple… 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?
Dexamethasone, IBI3003 and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
15 Aug 2026to 30 Jun 2031
Phase
Phase 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

  • 1. Aged at least 18 years old;
  • 2. Initial diagnosis of multiple myeloma documented according to International Myeloma Working Group (IMWG) diagnostic criteria.Multiple myeloma is defined as clonal bone marrow plasma cells ≥ 10% or biopsy-proven bony or extramedullary plasmacytoma, and any one or more of the following myeloma-defining events: • Evidence of end-organ damage attributable to the underlying plasma cell proliferative disorder, including the following: Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) above the upper limit of normal or corrected serum calcium > 2.75 mmol/L (> 11 mg/dL); renal insufficiency: creatinine clearance < 40 mL/min or serum creatinine > 177 μmol/L (> 2 mg/dL); anemia: hemoglobin value > 2 g/dL below the lower limit of normal or hemoglobin value < 10 g/dL; bone lesions: one or more osteolytic lesions on skeletal radiographs, computed tomography (CT), or positron emission tomography (PET)-CT.
  • Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥ 60%; involved-to-uninvolved serum free light chain ratio ≥ 100 [involved serum free light chain (FLC) level must be ≥ 100 mg/L]; > 1 focal lesion (at least 5 mm in size) on magnetic resonance imaging (MRI) examination.
  • 3.Safety run-in stage: Relapsed or refractory measurable multiple myeloma who have previously received ≥ 1 line of anti-myeloma therapy (including treatment with at least one proteasome inhibitor and one immunomodulatory drug), and the participant must be relapsed or refractory to the most recent treatment.Participants previously exposed to anti-CD38 monoclonal antibodies may also be enrolled (a 90-day washout period is required).
  • Note: Refractory to antimyeloma therapy requires failure to achieve minimal response (receipt of at least 2 complete cycles) or progression during treatment (no requirement for number of treatment cycles), or progression within 60 days of last treatment.
  • Cohort 1: Participants with newly diagnosed multiple myeloma who are ineligible for or refusing ASCT.
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  • Cohort 2: Participants with newly diagnosed multiple myeloma who are eligible for and interested in ASCT.
  • 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • 5. At least one of the following measurable disease indicators: • Serum M protein >= 5 g/L (for IgA and IgD subtypes, quantitative immunoglobulin measurement can be used to replace M protein); • Urine M protein >= 200mg/24h; • FLC test: involved FLC level >= 100 mg/L and abnormal FLC ratio (< 0.26 or > 1.65).

Who cannot join

  • 1. All subjects have previously received any treatment targeting BCMA and any treatment targeting GPRC5D.Participants who have received either a BCMA-directed or GPRC5D-directed therapy are allowed.
  • 2. Known active central nervous system (Central Nervous System, CNS) involvement or clinical symptoms of meningeal involvement of multiple myeloma.
  • 3. Has amyloidosis, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, solitary plasmacytoma, or smoldering (asymptomatic) multiple myeloma as defined by IMWG criteria.
  • 4. Patients with spinal cord compression resulting in limited self-care at present or within 6 months before signing the informed consent form, or expected to result in such restrictions during study participation.
  • 5. History of primary immunodeficiency.
  • 6. Other malignant tumors (except for cured basal cell or squamous cell skin cancer, superficial bladder cancer, prostatic intraepithelial neoplasia, cervical carcinoma in situ, or other non-invasive or indolent malignant tumors) at the time of enrollment or within 3 years prior to enrollment.
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  • 7. Received allogeneic hematopoietic stem cell transplantation within 6 months prior to the first dose of study drug, or received autologous stem cell transplantation within 3 months prior to the first dose of study drug.
  • 8. History of organ transplantation.
  • 9. Active graft-versus-host disease.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shijie Liu contact

+86 18701121959

shijie.liu@innoventbio.com

China1 site

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Jin LU, 010-88326666, jin1lu@sina.com

Other trials in China

About this study

Official title: A Multi-Center, Open-Label Phase II Study of IBI3003 in Combination With Anti-CD38 Monoclonal Antibody in Participants With Multiple Myeloma

This is an open-label, multi-center phase II study of IBI3003 in combination with anti-CD38 monoclonal antibody in adult subjects with multiple myeloma. This study includes a safety run-in period and 2 cohorts (Cohorts 1 and 2).In the safety run-in period, subjects with measurable relapsed or refractory multiple myeloma who had previously received at least 1 line of systemic anti-myeloma therapy and had a history of dual drug exposure (at least one proteasome inhibitor and one immunomodulatory agent) were enrolled, mainly to evaluate the safety and tolerability of IBI3003 in combination with anti-CD38 monoclonal antibody and to determine the recommended phase 2 dose of IBI3003 in combination with anti-CD38 monoclonal antibody.Cohort 1 mainly enrolls newly diagnosed MM(Multiple myeloma)patients who are ineligible for or refusing ASCT(Autologous Stem Cell Transplantation), and Cohort 2 enrolls newly diagnosed MM patients who are eligible for and willing to undergo ASCT. The 24-week MRD negative rate of IBI3003 in combination with anti-CD38 monoclonal antibody in the participant population is mainly evaluated.

Being tested
Dexamethasone, IBI3003, Lenalidomide, Daratumumab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    A potent synthetic glucocorticoid

  • IBI3003Biological

    Recombinant humanized anti-GPRC5D/BCMA/CD3 trispecific antibody injection

  • LenalidomideDrug

    An Oral Immunomodulator And Antineoplastic Drug

  • DaratumumabDrug

    Anti-cancer monoclonal antibody targeting CD38

Study groups in NCT07764861
Study groupRoleWhat they receive
treatment groupExperimentalNot described
Receives: Biological: IBI3003; Drug: Daratumumab
Standard-of-care control groupActive comparatorNot described
Receives: Drug: Dexamethasone; Drug: Lenalidomide; Drug: Daratumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRD（ Minimal Residue Disease) negativity rate at 24 weeks

    Defined as the percentage of participants who achieved MRD-negative status at or below the threshold of 10-5 at any time after the first treatment.

    Measured: 24weeks

  2. AE(Adverse event)

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

    Measured: 30Days

  3. TEAE(Treatment emergent adverse event)

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

    Measured: 30Days

  4. SAE（Serious Adverse Event）

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

    Measured: 30Days

  5. AESI( Adverse event of special interest)

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

    Measured: 30Days

Secondary outcomes (6)

  1. Progression-Free Survival (PFS)

    FPS is defined as the time from the date of randomization to the date of the first documented progression or death due to any case ,whichever occurs first

    Measured: 3years

  2. ORR(objective response rate)

    Defined as the proportion of participants achieving sCR, CR, VGPR, or PR according to the IMWG criteria

    Measured: 3years

  3. AE(Adverse event)

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

    Measured: 12Months

  4. TEAE(Treatment emergent adverse event)

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

    Measured: 12Months

  5. SAEs(serious adverse events)

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

    Measured: 12Months

  6. AESI( Adverse event of special interest)

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0

    Measured: 12Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2026
  2. Study start15 Aug 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07764861
Sponsor's protocol ID
CIBI3003A201
Status last verified
Aug 2026
First submitted
10 Aug 2026
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone, IBI3003 and Lenalidomide in people with Multiple Myeloma, run by Innovent Biologics (Suzhou) 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 9 inclusion and 9 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 14 Aug 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 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 Shijie Liu (+86 18701121959, shijie.liu@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRD（ Minimal Residue Disease) negativity rate at 24 weeks (time frame: 24weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07764861.

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 14 Aug 2026.

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