A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003

NCT07623798 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CIBI3003A301
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd)

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• PFS assessed by independent review committee

  PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria

  up to 24 months after the last enrolled participant receives the first dose of study drug

Secondary Outcomes (19)

• PFS assessed by investigator

  up to 24 months after the last enrolled participant receives the first dose of study drug

• Negativity rate of minimal residual disease (MRD)

  up to 24 months after the last enrolled participant receives the first dose of study drug

• Sustained MRD negativity rate

  up to 24 months after the last enrolled participant receives the first dose of study drug

• 6-month MRD negativity rate.

  up to 24 months after the last enrolled participant receives the first dose of study drug

• 12-month MRD negativity rate

  up to 24 months after the last enrolled participant receives the first dose of study drug

Study Arms (2)

the investigator's choice regimen (DPd or PVd)

ACTIVE COMPARATOR

participants will receive DPd or PVd until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.

Drug: Pomalidomide Capsules; Drug: Bortezomib for Injection; Drug: Daratumumab Injection (Subcutaneous Injection)

IBI3003

EXPERIMENTAL

participants will receive IBI3003 until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.

Drug: IBI3003

Interventions

Pomalidomide Capsules DRUG

1. The DPd treatment regimen, one cycle every 28 days: Pomalidomide 4mg/d orally, on days 1-21; 2. The PVd treatment regimen, one cycle every 21 days: Pomalidomide 4 mg/d orally, on days 1-14 of each treatment cycle;

Also known as: P

the investigator's choice regimen (DPd or PVd)

Bortezomib for Injection DRUG

The PVd treatment regimen, with one cycle every 21 days: Bortezomib on days 1, 4, 8, and 11 of cycles 1-8, and on days 1 and 8 from cycle 9 onwards.

Also known as: V

the investigator's choice regimen (DPd or PVd)

Daratumumab Injection (Subcutaneous Injection) DRUG

The DPd treatment regimen, one cycle every 28 days: on days 1, 8, 15, and 22 of cycles 1 and 2; on days 1 and 15 from cycles 3-6; and on day 1 from cycle 7 onwards.

Also known as: D

the investigator's choice regimen (DPd or PVd)

IBI3003 DRUG

According to body weight

Also known as: trispecific antibody

IBI3003

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.
• At least one of the following measurable disease indicators:
• Serum M-protein ≥ 5 g/L（For IgA and IgD subtypes, it is recommended to use quantitative immunoglobulin measurements instead of M protein）
• Urine M-protein ≥200 mg/24h
• Serum free light chain (FLC) test: affected FLC level ≥100 mg/L and abnormal serum FLC ratio (\<0.26 or \>1.65)
• Life expectancy ≥3 months.
• Fertile females and sexually active fertile males must agree to use highly effective contraception (failure rate \<1% per year) during the study and for 90 days after the last dose of the investigational drug. For participants in the clinical trial, contraceptive measures must comply with local regulations regarding the use of contraceptive methods. Females and males must agree not to donate eggs (ova, oocytes) or sperm during the study and for 90 days after the last dose of the investigational drug.
• Willing and able to comply with the prohibitions and restrictions specified in this protocol.

You may not qualify if:

• Previous treatment with any BCMA-targeted therapy and any GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy are allowed to participate in the study.
• Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
• Spinal cord compression that leads to limited self-care ability occurs within six months prior to informed consent or is expected to occur in the near future.
• Have history of primary immunodeficiency.
• Have history of organ transplantation.
• Have received allogeneic hematopoietic stem cell transplantation within 6 months before the first administration of the study drug, or have received autologous stem cell transplantation within 3 months before the first administration of the study drug.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

ZhongShan Hospital FuDan University

Shanghai, Shanghai Municipality, 132101, China

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

pomalidomide; Bortezomib; Injections; daratumumab; Injections, Subcutaneous; Fumigant 93

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Haiyan Zhu

CONTACT

0512-69566088; haiyan.zhu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 3, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

CN (1)