Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
NCT03145181 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 302
Last updated 2026-04-23
Summary
The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.
Conditions
Interventions
- DRUG
-
Teclistamab (IV)
Participants will receive IV infusion of Teclistamab.
- DRUG
-
Teclistamab(SC)
Participants will receive SC injection of Teclistamab.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-16
- Primary Completion
- 2025-09-25
- Completion
- 2027-05-28
- FDA Drug
- Yes
Countries
- United States
- France
- Netherlands
- Spain
- Sweden
Study Locations
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