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Clinical Trials in the USA / NCT03145181
Active, not recruiting Phase 1

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

NCT03145181 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 1
Started
2017-05-16
Last updated
2026-08-28

Condition(s) studied

Hematological Malignancies

Investigational drug(s) / intervention(s)

Teclistamab (IV)Teclistamab(SC)

Teclistamab (IV): Participants will receive IV infusion of Teclistamab.

Teclistamab(SC): Participants will receive SC injection of Teclistamab.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria * Measurable multiple myeloma that is relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory multiple myeloma or be intolerant of those established multiple myeloma therapies, and a candidate for Teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory drug and anti-CD38 monoclonal antibody in any order during the course of treatment. Participants who could not tolerate a proteasome inhibitor or immunomodulatory drugs and an anti-CD38 monoclonal antibody are allowed * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Female participants of childbearing potential must use acceptable method of contraception * Participants must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease Exclusion Criteria: * Prior treatment with any B cell maturation antigen (BCMA) targeted therapy * Prior antitumor therapy as follows, before the first dose of study drug: Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less; Monoclonal antibody treatment for multiple myeloma within 21 days; Cytotoxic therapy within 21 days; Proteasome inhibitor therapy within 14 days; Immunomodulatory agent therapy within 7 days; Gene modified adoptive cell therapy (example, chimeric antigen receptor modified T cells, natural killer \[NK\] cells) within 3 months; Radiotherapy within 14 days or focal radiation within 7 days * Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy * Received a cumulative dose of corticosteroids equivalent to \>= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication) * Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
City of Hope Duarte California
Colorado Blood Cancer Institute Denver Colorado
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects New York New York
Levine Cancer Institute Charlotte North Carolina
University of Pennsylvania Philadelphia Pennsylvania
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03145181 on ClinicalTrials.gov ↗ ← All trials in the USA