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
Janssen Research & Development, LLC
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: For participants with relapsed or refractory multiple myeloma: * Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria * Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior li…
Interventions
- DrugJNJ-79635322
JNJ-79635322 will be administered as SC injection.
Locations (29)
- City of HopeDuarte, California
- City of Hope Orange County Lennar Foundation Cancer CenterIrvine, California
- University of California San FranciscoSan Francisco, California
- Colorado Blood Cancer InstituteDenver, Colorado
- Icahn School of Medicine at Mt. SinaiNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York