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A Open-Label Phase in Participants With Multiple Myeloma

NCT07764861 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-14

No results posted yet for this 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.

Conditions

Interventions

DRUG

Dexamethasone

A potent synthetic glucocorticoid

BIOLOGICAL

IBI3003

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

DRUG

Lenalidomide

An Oral Immunomodulator And Antineoplastic Drug

DRUG

Daratumumab

Anti-cancer monoclonal antibody targeting CD38

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2026-12-31
Completion
2031-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764861 on ClinicalTrials.gov