On Monday, January 26, Innovent Biologics announced via press release that the U.S. Food and Drug Administration has granted fast track designation to anti-GPRC5D/BCMA/CD3 trispecific antibody IBI3003 as treatment for relapsed/refractory multiple myeloma (RRMM).  

According to Innovent, “this designation applies to the treatment of relapsed or refractory multiple myeloma, (R/R MM) in patients who have received four or more lines of previous anti-myeloma therapies, that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.” 
 
IBI3003 is an investigational cancer medicine discovered and developed using Innovent’s Sanbody® platform, with its development progressing globally. IBI3003 is currently being studied in a Phase 1/2 clinical trial for RRMM patients in China and Australia, with a Phase 1/2 trial in the United States planned to begin soon. 

At the American Society of Hematology (ASH) Annual Meeting on December 7, 2025, early clinical results showed that IBI3003 had a generally manageable safety profile and promising signs of efficacy in patients whose disease had progressed after two or more prior lines of therapy. 

In this study, 39 patients with RRMM who had previously received a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody were treated with IBI3003 at doses ranging from 0.1 to 800 μg/kg. As of November 7, 2025, the median follow-up time was 3.25 months, and patients received treatment for a median of about 12 weeks. 

Among 24 patients treated at doses of 120 μg/kg or higher, the overall response rate (ORR) was 83.3%. This included 4 stringent complete responses (sCR), 7 very good partial responses (VGPR), and 9 partial responses (PR). High response rates were also seen in patients with difficult-to-treat disease: 80% in those with extramedullary disease (EMD) and 77.8% in those previously treated with BCMA- and/or GPRC5D-targeted therapies. All patients who achieved a complete response or better were negative for minimal residual disease (MRD), measured by next-generation sequencing at a sensitivity of 10⁻⁵. 

Regarding safety, all cases of cytokine release syndrome (CRS) were mild to moderate (Grade 1–2). Only two cases of mild to moderate immune effector cell-associated neurotoxicity syndrome (ICANS) were reported. Most side effects related to GPRC5D targeting, such as effects on the mouth, skin, and nails, were also mild to moderate, although two patients experienced Grade 3 skin rash. 

The FDA's Fast Track Designation is a program designed to speed the development and review of treatments for serious diseases with unmet medical needs through closer interaction with the FDA. 
 
Reference:  
Innovent Announces IBI3003 (GPRC5D/BCMA/CD3 Trispecific Antibody) Receives Fast Track Designation from the U.S. FDA for Relapsed or Refractory Multiple Myeloma, Innovent Biologics, Inc. Press release, January 26, 2026.