Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03145181
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Hematological Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab (IV) — DRUG
    Participants will receive IV infusion of Teclistamab.
  • Teclistamab(SC) — DRUG
    Participants will receive SC injection of Teclistamab.

Study Details

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.

Key Dates

Start date
May 16, 2017
Status verified
Jun 2026
Primary completion
Sep 25, 2025
Completion
May 28, 2027

Study Design

Enrollment
302 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation (IV)
    Participants will receive Teclistamab intravenously (IV).
  • Experimental: Part 2: Dose Expansion (IV)
    Participants will receive Teclistamab IV.
  • Experimental: Part 1: Dose Escalation (SC)
    Participants will receive Teclistamab subcutaneously (SC).
  • Experimental: Part 2: Dose Expansion (SC)
    Participants will receive Teclistamab SC.

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: Up to Day 28 ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Colorado Blood Cancer InstituteDenverColorado80218-
Icahn School of Medicine at Mount Sinai Program for the Protection of Human SubjectsNew YorkNew York10029-
Levine Cancer InstituteCharlotteNorth Carolina28204-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAColorado Blood Cancer Institute· Denver, COIcahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects· New York, NYLevine Cancer Institute· Charlotte, NCUniversity of Pennsylvania· Philadelphia, PA

Related Studies