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

A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

First Posted Date
2021-01-25
Last Posted Date
2025-05-04
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
140
Registration Number
NCT04722146
Locations
🇺🇸

Emory University, Atlanta, Georgia, United States

🇺🇸

Weill Cornell Medical College, New York, New York, United States

🇺🇸

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

and more 24 locations

A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Phase 1
Active, not recruiting
Conditions
Hematologic Malignancies
Interventions
First Posted Date
2021-01-06
Last Posted Date
2025-04-03
Lead Sponsor
Janssen Pharmaceutical K.K.
Target Recruit Count
40
Registration Number
NCT04696809
Locations
🇯🇵

National Hospital Organization Okayama Medical Center, Okayama, Japan

🇯🇵

Kameda Medical Center, Chiba, Japan

🇯🇵

Ogaki Municipal Hospital, Gifu, Japan

and more 12 locations

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Phase 1
Active, not recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2020-10-14
Last Posted Date
2025-04-03
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
228
Registration Number
NCT04586426
Locations
🇨🇦

Arthur J E Child Comprehensive Cancer Centre, Calgary, Alberta, Canada

🇺🇸

University of Alabama at Birmingham, Comprehensive Cancer Center, Birmingham, Alabama, United States

🇺🇸

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

and more 37 locations

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Phase 2
Active, not recruiting
Conditions
Hematological Malignancies
Interventions
First Posted Date
2020-09-21
Last Posted Date
2025-04-04
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
194
Registration Number
NCT04557098
Locations
🇩🇪

Universitaetsklinikum Leipzig, Leipzig, Germany

🇨🇦

University Health Network UHN Princess Margaret Cancer Centre, Toronto, Ontario, Canada

🇫🇷

CHRU Hôpital Jean Bernard, Poitiers, France

and more 48 locations

A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma

Phase 1
Active, not recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2019-09-30
Last Posted Date
2025-05-04
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
290
Registration Number
NCT04108195
Locations
🇨🇦

Arthur J E Child Comprehensive Cancer Centre, Calgary, Alberta, Canada

🇺🇸

City of Hope National Medical Center, Duarte, California, United States

🇺🇸

City of Hope Orange County Lennar Foundation Cancer Center, Irvine, California, United States

and more 21 locations

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

Phase 1
Active, not recruiting
Conditions
Hematological Malignancies
Interventions
Drug: Teclistamab(SC)
First Posted Date
2017-05-09
Last Posted Date
2025-04-25
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
282
Registration Number
NCT03145181
Locations
🇺🇸

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

and more 10 locations
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