Johnson & Johnson Launches First-in-Class Trispecific Antibody JNJ-79635322 into Phase III Trial for Relapsed/Refractory Multiple Myeloma

Dec 03, 2025 11:26 CST Updated 11:26

Johnson & Johnson

Medical Device R&D and Manufacturer

On December 2 local time, Johnson & Johnson registered a clinical trial on the ClinicalTrials website.JNJ-79635322 TreatmentRelapsed or Refractory Multiple Myeloma（RRMM）Patient's Phase III Study Trilogy-4.

Source:ClinicalTrials Official Website

Trilogy-4 Is a Phase III randomized study designed toComparison of JNJ-79635322 and Anti-BCMAxCD3 Bispecific AntibodyHaving received at least 3 prior lines of therapy(Including proteasome inhibitors, immunomodulators, and anti-CD38 antibodies)Efficacy in RRMM Patients.

The study plans to enroll 400 participants, with the primary endpoints being ORR and PFS. The dosing regimen is as follows:

Source:ClinicalTrials Official Website

JNJ-79635322 is developed by Johnson & Johnson.A new generation of tri-specific antibody, targeting BCMA, GPRC5D, and CD3. At the 2025 ASCO conference, Johnson & Johnson disclosed the Phase I human study data of this drug for the first time.

As of2025 Year1 Month15 Day,126 Example: Patient AcceptanceJNJ-79635322 Treatment（36 Example Acceptance100 mg，Q4W）, the median follow-up time was8.2 months. In patients whose efficacy can be evaluated,RP2D Dose Group（n=36）ORR For86%（75% ≥Very Good Partial RemissionVGPR），Overall（n=124）ORR For73%（66%≥VGPR）。

Among them, in those who have not received anti-BCMA/GPRC5D Among the treated patients,RP2D Dose Group（n=27） ORR Achieve100%（89%≥VGPR），And all patients continued to experience relief.(Median follow-up8.5 Months)The median time to first remission was 1.2 months.

In terms of safety,99% The patient experienced ≥1 SecondAE, the most common including cytokine release syndrome（CRS，59%；None ≥3 Level), Nail-relatedAE（1/2 Level56%）, Abnormal taste（1/2 Level56%）、Neutropenia（48%；3/4 Level41%）Non-rash skinAE（47%；3/4 Level1%）。16% of patientsWeight loss occurs(Without ≥3 Level)，16% Rash appears(None ≥3 Level)，2% OccurrenceICANS(All are1 Level)，75% Infection Occurs（3/4 Level28%）。5 NamesThe patient experienced dose-limiting toxicity,4 NamesDue toAE Death.

Insight database shows that currently, there are 5 CD3/BCMA/GPRC5D trispecific antibodies in the clinical stage globally, excluding Johnson & Johnson'sApart from JNJ-79635322, the other four are all domestically produced in China, coming fromTian Guangshi（MBS314）, Innovent Biologics（IBI3003）, Qilu Pharmaceutical（QLS4131）And Simcere Pharmaceutical（SIM0500）。

Source:Insight Database

Among them,Innovent and QiluThe clinical results of the two tri-specific antibodies will be announced for the first time at this year's ASH conference.