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Can a Triple-Action antibody deepen remissions in myeloma?

NCT ID NCT07764861

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This phase II trial is testing whether a new investigational drug called IBI3003, when combined with an existing anti-CD38 antibody (daratumumab), can improve outcomes for people with multiple myeloma. The study includes patients with relapsed or refractory disease, as well as newly diagnosed patients who are either eligible or ineligible for stem cell transplantation. The main goal is to see if this combination can achieve a high rate of minimal residual disease (MRD) negativity at 24 weeks, which indicates a very deep level of remission.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IBI3003 (a trispecific antibody) combined with daratumumab (anti-CD38 antibody), plus dexamethasone and lenalidomide
What this could lead to
If successful, this combination could offer a new, more effective treatment option for multiple myeloma, potentially leading to deeper remissions and longer disease control.
What could go wrong
This is an early-phase study with a small number of participants. The combination may cause significant side effects, and the results may not confirm long-term benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. 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). 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 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

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Other studies related to the condition(s) this trial covers.