Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Participants will receive Teclistamab intravenously (IV).

Participants will receive Teclistamab IV.

Participants will receive Teclistamab subcutaneously (SC).

Participants will receive Teclistamab SC.

Participants will receive IV infusion of Teclistamab.

Teclistamab (IV)

Participants will receive SC injection of Teclistamab.

Teclistamab(SC)

Study Contact

Janssen Research & Development, LLC Clinical Trial

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.

The study will be conducted in 2 parts, separately for IV and SC administration: dose escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of Teclistamab administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as 2 years after the last participant in Part 3 has received his or her initial dose of teclistamab. Study record NCT04557098 is Phase 2 part of this study and study record NCT03145181 is Phase 1 part of this study.

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

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

The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Concentration assessment will be done to evaluate the effect of Teclistamab.

Antibodies to Teclistamab will be assessed to evaluate potential immunogenicity.

Preliminary antitumor activity of Teclistamab will be done using the International Myeloma Working Group (IMWG) response criteria.

Biomarker assessment may be done to evaluate the effect of Teclistamab.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma	NCT03145181	Hematological M...	Teclistamab (IV... Teclistamab(SC)	18 Years -	Janssen Research & Development, LLC
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma	NCT03145181	Hematological M...	Teclistamab (IV... Teclistamab(SC)	18 Years -	Janssen Research & Development, LLC
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma	NCT03145181	Hematological M...	Teclistamab (IV... Teclistamab(SC)	18 Years -	Janssen Research & Development, LLC

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