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First-in-human trial of JNJ-5322 in patients with RRMM: Preliminary phase I results
Advances in bispecific antibodies and CAR T-cell therapies have improved outcomes in patients with relapsed/refractory multiple myeloma (RRMM). However, there remains potential to further improve outcomes while reducing the treatment burden in this population. JNJ-79635322 (JNJ-5322) is a next-generation trispecific antibody with dual targeting and novel binding ability for BCMA and GPRC5D domains. During the European Hematology Association 2025 Congress, Rakesh Popat presented preliminary findings of a phase I trial (NCT05652335) assessing the safety and efficacy of JNJ-5322 in patients with RRMM.1 Patients with triple-class-exposed RRMM were included in the all-doses cohort (N = 147), with 36 patients in the recommended phase II dose (RP2D) cohort. JNJ-5322 doses ranged from 5 to 300 mg. The primary objectives were to identify RP2D, safety, and efficacy. The RP2D was 5 mg subcutaneously followed by 100 mg subcutaneously administered every 4 weeks.
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Key learnings |
One DLT and one Grade 5 TEAE occurred at RP2D, with four DLTs and four Grade 5 TEAEs across all doses. Grade 3/4 infections were reported in 33.3% and 28.6% of patients in the RP2D and all-doses cohorts, respectively. |
At RP2D, no ICANS were reported. Prophylactic tocilizumab decreased CRS incidence and severity, with CRS events reported in 20% of patients with prophylactic tocilizumab vs 69.2% of patients without. |
In the RP2D and the all-doses cohorts, respectively, all grade taste-related oral TEAEs were reported in 58.3% and 57.8% of patients, with Grade 1/2 weight loss (usually transient) reported in 6% and 12% of patients (no Grade ≥3 weight loss). |
In BCMA/GPRC5D-naïve patients, ORRs were 66.7%, 100%, and 100% in patients receiving 50 mg, RP2D, and 300 mg doses, respectively. 12-month PFS was 95% and 74.1% in the RP2D and all-doses cohorts, respectively. |
JNJ-5322 demonstrated improved or similar safety compared with other BCMA/GPRC5D BsAbs and an ORR comparable with CAR T-cell therapies. JNJ-5322 has the potential to facilitate convenient outpatient dosing in patients with RRMM. |
BCMA, B-cell maturation agent; BsAb, bispecific antibody; CAR, chimeric antigen receptor; CRS, cytokine release syndrome; DLT, dose-limiting toxicity; GPRC5D, G-protein coupled receptor class C group 5 member D; ICANS, immune effector cell-associated neurotoxicity syndrome; ORR, overall response rate; PFS, progression-free survival; RP2D, recommended phase II dose; RRMM, relapsed/refractory multiple myeloma; TEAE, treatment-emergent adverse event.
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