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Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
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.
Official title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody in Subjects With Relapsed or Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
302
Start Date
2017-05-16
Completion Date
2027-05-28
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Teclistamab (IV)
Participants will receive IV infusion of Teclistamab.
Teclistamab(SC)
Participants will receive SC injection of Teclistamab.
Locations (13)
City of Hope
Duarte, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Hospices Civils de Lyon HCL
Lyon, France
CHRU Tours Hopital Bretonneau
Tours, France
VU Medisch Centrum
Amsterdam, Netherlands
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain
Hosp Clinic de Barcelona
Barcelona, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Hosp Clinico Univ de Salamanca
Salamanca, Spain
Haematology Centre, R 51
Stockholm, Sweden