NCT05652335

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated AL Amyloidosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D\[s\]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

Conditions

• Relapsed or Refractory Multiple Myeloma
• Previously Treated Amyloid Light-chain (AL) Amyloidosis

Interventions

Type	Name	Description
DRUG	JNJ-79635322	JNJ-79635322 will be administered as SC injection.

Timeline

• Start date: 2022-11-22
• Primary completion: 2027-04-19
• Completion: 2028-08-07
• First posted: 2022-12-15
• Last updated: 2026-04-13

Locations

29 sites across 7 countries: United States, Belgium, France, Japan, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study