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ACTIVE NOT RECRUITING
NCT03145181
PHASE1/PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

Teclistamab (IV)

Participants will receive IV infusion of Teclistamab.

DRUG

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