A Open-Label Phase in Participants With Multiple Myeloma

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07764861
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    A potent synthetic glucocorticoid
  • IBI3003 — BIOLOGICAL
    Recombinant humanized anti-GPRC5D/BCMA/CD3 trispecific antibody injection
  • Lenalidomide — DRUG
    An Oral Immunomodulator And Antineoplastic Drug
  • Daratumumab — DRUG
    Anti-cancer monoclonal antibody targeting CD38

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Aug 15, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2031

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: treatment group
  • Active Comparator: Standard-of-care control group

Primary Outcome Measure

MRD（ Minimal Residue Disease) negativity rate at 24 weeks [ Time Frame: 24weeks ]

Central Contacts

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