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

Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse

Phase 2
Not yet recruiting
Conditions
Recurrent Multiple Myeloma
Refractory Multiple Myeloma
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Procedure: FDG-Positron Emission Tomography
First Posted Date
2025-04-29
Last Posted Date
2025-05-07
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
80
Registration Number
NCT06948084

Teclistamab in Previously Treated AL Amyloidosis

Phase 2
Not yet recruiting
Conditions
AL Amyloidosis
Interventions
First Posted Date
2025-04-20
Last Posted Date
2025-04-20
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
30
Registration Number
NCT06935162

Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma

Phase 2
Not yet recruiting
Conditions
Multiple Myleoma
Multiple Myeloma in Relapse
Multiple Myeloma Refractory
Interventions
First Posted Date
2025-03-25
Last Posted Date
2025-04-03
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
52
Registration Number
NCT06880601

The Norwegian Immunotherapy in Multiple Myeloma Study

Recruiting
Conditions
Myeloma Multiple
Plasma Cell Leukemia
AL Amyloidosis
First Posted Date
2025-03-03
Last Posted Date
2025-03-03
Lead Sponsor
St. Olavs Hospital
Target Recruit Count
400
Registration Number
NCT06855121
Locations
🇳🇴

Sørlandet hospital, Kristiansand, Norway

🇳🇴

Bærum Hospital, Bærum, Norway

🇳🇴

Sørlandet Hospital - Arendal, Arendal, Norway

and more 20 locations

Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

Phase 2
Recruiting
Conditions
Multiple Myeloma, Newly Diagnosed
Interventions
First Posted Date
2025-01-03
Last Posted Date
2025-03-20
Lead Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Target Recruit Count
10
Registration Number
NCT06758375
Locations
🇲🇽

Hospital Universitario Dr. Jose E. Gonzalez, Monterrey, Nuevo León, Mexico

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Not Applicable
Recruiting
Conditions
AL Amyloidosis
Interventions
First Posted Date
2024-11-21
Last Posted Date
2025-04-24
Lead Sponsor
Peking University People's Hospital
Target Recruit Count
20
Registration Number
NCT06699394
Locations
🇨🇳

Peking University Peoples Hospital, Beijing, Beijing, China

🇨🇳

Fuxing Hospital affiliated to Capital Medical University, Beijing, China

A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis

Phase 2
Not yet recruiting
Conditions
AL Amyloidosis
Interventions
First Posted Date
2024-10-21
Last Posted Date
2025-04-13
Lead Sponsor
European Myeloma Network B.V.
Target Recruit Count
30
Registration Number
NCT06649695
Locations
🇳🇱

UMC Utrecht, Utrecht, Netherlands

🇦🇺

South Australia Health, Adelaide, Australia

🇦🇺

Westmead Hospital, Sydney, Australia

and more 7 locations

ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma

Phase 1
Recruiting
Conditions
Recurrent Multiple Myeloma
Refractory Multiple Myeloma
Interventions
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Other: Medical Chart Review
Procedure: Biospecimen Collection
First Posted Date
2024-09-19
Last Posted Date
2025-01-28
Lead Sponsor
University of Washington
Target Recruit Count
20
Registration Number
NCT06588660
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

First Posted Date
2024-08-29
Last Posted Date
2025-04-28
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
40
Registration Number
NCT06577025
Locations
🇪🇸

Hosp. Univ. 12 de Octubre, Madrid, Spain

🇺🇸

City of Hope, Duarte, California, United States

🇺🇸

University of California San Francisco, San Francisco, California, United States

and more 9 locations

Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

First Posted Date
2024-07-17
Last Posted Date
2024-07-17
Lead Sponsor
North Estonia Medical Centre
Target Recruit Count
50
Registration Number
NCT06505369
Locations
🇳🇴

Oslo University Hospital, Oslo Myeloma Centre, Oslo, Norway

🇳🇴

Stavanger University Hospital, Stavanger, Norway

🇩🇰

Vejle hospital, Vejle, Denmark

and more 4 locations
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