ClinicalTrials.gg
Not yet recruitingNCT07764861Updated Aug 14, 2026

A Open-Label Phase in Participants With Multiple Myeloma

A Phase 2 interventional study of Dexamethasone and IBI3003 in Multiple Myeloma, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 447 studies in Multiple Myeloma with a site in China — 237 open to participants now, 274 under way, 47 of them phase 3. Multiple Myeloma · China.

Planned enrollment
89th of 405
120 · median 40
Started
2026
with 52 others
Phase 2
59 of 447
32 open now
Primary completion
2026-12
later than 111 of 273 live
Registered
438th of 447
by date

Among the 447 studies in Multiple Myeloma with a site in China, this one is the 89th largest by planned enrollment of the 405 interventional ones that give a count, is one of 53 that started in 2026, is one of 59 in phase 2, reaches primary completion later than 111 of the 273 other live ones, and was the 438th registered.

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

237 of the 447 studies in Multiple Myeloma with a site in China are open now. Recruiting first, the newest first:

232 more — sign in →

All 237 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 584 Multiple Myeloma studies recruiting now, 429 (73%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 447 studies in Multiple Myeloma with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Multiple Myeloma

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 -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 or corrected serum calcium > 2.75 mmol/L (> 11 mg/dL); renal insufficiency: \< 40 mL/min or serum creatinine > 177 μmol/L (> 2 mg/dL); anemia: 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 : 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: 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 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 .

Cohort 2: Participants with newly diagnosed multiple myeloma who are eligible for and interested in ASCT.

  • 4. (ECOG) performance status score of 0 or 1.
  • 5. At least one of the following 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).

Exclusion criteria

Exclusion Criteria:

  • 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 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.
  • 7. Received 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 .
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    treatment group

    Biological: IBI3003 · Drug: Daratumumab

  • Active comparator
    Standard-of-care control group

    Drug: Dexamethasone · Drug: Lenalidomide · Drug: Daratumumab

Interventions

  • A potent synthetic glucocorticoid

  • BiologicalIBI3003

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

  • An Oral Immunomodulator And Antineoplastic Drug

  • Anti-cancer monoclonal antibody targeting CD38

06

What researchers measure

Primary outcomes

  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.

    Time frame: 24weeks

  2. AE(Adverse event)

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

    Time frame: 30Days

  3. TEAE(Treatment emergent adverse event)

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

    Time frame: 30Days

  4. SAE(Serious Adverse Event)

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

    Time frame: 30Days

  5. AESI( Adverse event of special interest)

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

    Time frame: 30Days

Secondary outcomes

  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

    Time frame: 3years

  2. ORR(objective response rate)

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

    Time frame: 3years

  3. AE(Adverse event)

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

    Time frame: 12Months

  4. TEAE(Treatment emergent adverse event)

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

    Time frame: 12Months

  5. SAEs(serious adverse events)

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

    Time frame: 12Months

  6. AESI( Adverse event of special interest)

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

    Time frame: 12Months

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.

Of 93 industry-sponsored phase 2 interventional studies under Multiple Myeloma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 77. This study's planned 4 months is below that.

Counting every sponsor, half of 505 studies reached it within 57 months; a quarter within 35 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 14, 2026
StartEst.
Aug 15, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Jun 30, 2031
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07764861
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2031 (estimated)
Last update
Aug 14, 2026

Study contacts

Shijie Liu
Contact
shijie.liu@innoventbio.com
+86 18701121959

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: GPRC5D/BCMA/CD3-targeting T-cell Engager IBI3003

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