MedPath

Teclistamab

Generic Name
Teclistamab
Brand Names
Tecvayli
Drug Type
Biotech
CAS Number
2119595-80-9
Unique Ingredient Identifier
54534MX6Z9
Background

Teclistamab is an IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA) expressed on malignant multiple myeloma cells. Teclistamab consists of an anti-BCMA arm and an anti-CD3 arm connected via two interchain disulfide bonds, allowing the drug to recruit CD3-expressing T cells to BCMA-expressing cells to promote T cell–mediated cytotoxicity.

On August 24, 2022, the European Commission (EC) granted conditional marketing authorization of teclistamab as first-in-class bispecific antibody for the treatment of multiple myeloma, marking its first global approval. Teclistamab was later granted accelerated approval by the FDA on October 25, 2022.

Indication

Teclistamab is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Teclistamab is approved by the EC and FDA under conditional marketing authorization and accelerated approval, respectively. New evidence for this drug will be continuously monitored and reviewed, which will affect continued approval for the drug's indication.

Associated Conditions
Refractory Multiple Myeloma, Relapsed Multiple Myeloma

GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

First Posted Date
2023-01-25
Last Posted Date
2024-10-23
Lead Sponsor
University of Heidelberg Medical Center
Target Recruit Count
130
Registration Number
NCT05695508
Locations
🇩🇪

Charité University Medicin Berlin, Berlin, Germany

🇩🇪

Clinic Chemnitz gGmbH, Chemnitz, Germany

🇩🇪

University Clinic Technical University Dresden, Dresden, Germany

and more 8 locations

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

Phase 3
Recruiting
Conditions
Relapsed or Refractory Multiple Myeloma
Interventions
First Posted Date
2022-10-07
Last Posted Date
2025-04-27
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
650
Registration Number
NCT05572515
Locations
🇺🇸

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

🇧🇪

CHR de la Citadelle, Liege, Belgium

🇧🇷

Hospitais Integradaos da Gavea S/A - DF Star, Brasilia, Brazil

and more 206 locations

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Phase 2
Recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2022-10-07
Last Posted Date
2024-08-02
Lead Sponsor
University Hospital, Lille
Target Recruit Count
74
Registration Number
NCT05572229
Locations
🇫🇷

Chu Amiens - Hopital Sud, Amiens, France

🇫🇷

Chru Angers, Angers, France

🇫🇷

Ch D'Avignon, Avignon, France

and more 26 locations

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

First Posted Date
2022-09-23
Last Posted Date
2025-04-27
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
1590
Registration Number
NCT05552222
Locations
🇨🇭

Kantonsspital St Gallen, St. Gallen, Switzerland

🇧🇷

Liga Norte Riograndense Contra O Cancer, Natal, Brazil

🇧🇷

Complexo Hospitalar de Niteroi, Niteroi, Brazil

and more 200 locations

Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

Phase 2
Recruiting
Conditions
High-risk Smoldering Multiple Myeloma
Smoldering Multiple Myeloma
Multiple Myeloma
Interventions
First Posted Date
2022-07-22
Last Posted Date
2025-04-24
Lead Sponsor
Irene Ghobrial, MD
Target Recruit Count
52
Registration Number
NCT05469893
Locations
🇺🇸

Oregon Health & Science University, Portland, Oregon, United States

🇺🇸

Colorado Blood Cancer Institute, Denver, Colorado, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients

Conditions
Relapsed or Refractory Multiple Myeloma
First Posted Date
2022-07-19
Last Posted Date
2022-11-15
Lead Sponsor
Janssen Research & Development, LLC
Registration Number
NCT05463939

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Phase 1
Active, not recruiting
Conditions
Relapsed/ Refractory Multiple Myeloma
Interventions
First Posted Date
2022-04-21
Last Posted Date
2025-04-03
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
74
Registration Number
NCT05338775
Locations
🇺🇸

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

Colorado Blood Cancer Institute, Denver, Colorado, United States

and more 16 locations

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Phase 3
Recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2022-02-17
Last Posted Date
2025-04-15
Lead Sponsor
Stichting European Myeloma Network
Target Recruit Count
1594
Registration Number
NCT05243797
Locations
🇦🇹

LKH Hochsteiermark, Vienna, Austria

🇺🇸

The University of Arizona Cancer Center, Phoenix, Arizona, United States

🇺🇸

University of California-Davis Cancer Center, Sacramento, California, United States

and more 205 locations

Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)

Conditions
Multiple Myeloma
First Posted Date
2021-12-17
Last Posted Date
2025-04-06
Lead Sponsor
Janssen Research & Development, LLC
Registration Number
NCT05161598

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

Phase 3
Active, not recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2021-10-19
Last Posted Date
2025-04-27
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
587
Registration Number
NCT05083169
Locations
🇸🇪

Skanes universitetssjukhus, Lund, Sweden

🇸🇪

Norrlands Universitetssjukhus, Umea, Sweden

🇸🇪

Akademiska Sjukhuset, Uppsala, Sweden

and more 171 locations
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