• Recruiting

NCT04557098: Phase 2- Teclistamab, in Participants With Relapsed or Refractory Myeloma (MajesTEC-1)

Updated: Sep 15

MajesTEC1 study

A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1)

MajesTEC1

Relapsed & Refractory Multiple Myeloma


The purpose of this study is evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).


Study record NCT03145181 is Phase 1 part of this study and study record NCT04557098 is Phase 2 part of this study.


NCT03145181 - MajesTEC-1 - Parts 1-2

Phase 1 - Dose escalation study of teclistamab, a humanized BCMA*CD3 bispecific antibody, in participants with relapsed or refractory multiple myeloma (MajesTEC-1)


NCT04557098 - MajesTEC-1 - Part 3

Phase 2 - A study of teclistamab, a humanised BCMA x CD3 bispecific antibody in participants with relapsed or refractory multiple myeloma


Sponsor

Janssen Research & Development, LLC

 

Multiple Locations

International Study

 

ClinicalTrials.gov Identifier: NCT03145181

Official Title: A Phase 1/2, 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

First Posted : September 21, 2020

Click here to see details on ClinicalTrials.gov

 

JNJ 64007957

JNJ 64007957 - Teclistamab

 

Drug: Teclistamab

 

Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma

PMID: 32956453; Blood Adv; Sep 2020

Click here to see details.

 

896 Updated Results from MajesTEC-1: Phase 1/2 Study of Teclistamab, a B-Cell Maturation Antigen x CD3 Bispecific Antibody, in Relapsed/Refractory Multiple Myeloma

Program: Oral and Poster Abstracts

Type: Oral

Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Immune Therapy for Multiple Myeloma

Hematology Disease Topics & Pathways:

Clinical Trials, Biological, Bispecific Antibody Therapy, Clinical Research, Plasma Cell Disorders, Diseases, Therapies, Immunotherapy, Lymphoid Malignancies

Monday, December 13, 2021: 6:30 PM

Learn more

 

RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.

Janssen will present the results from the Phase 1 and 2 MajesTEC-1 (Abstract #896) studies evaluating teclistamab (BCMAxCD3), an investigational, off-the-shelf, T-cell redirecting bispecific antibody in heavily pre-treated patients with multiple myeloma.

Click here for details

 

Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study

PMID: 34388396; Lancet; Aug 2021

Click here to see details

 

EHA2022 Oral Presentation

EHA 2022 - HYBRID - JUNE 9-17 - VIENNA

EVALUATING TECLISTAMAB IN PATIENTS WITH RELAPSED/ REFRACTORY MULTIPLE MYELOMA FOLLOWING EXPOSURE TO OTHER B-CELL MATURATION ANTIGEN (BCMA)-TARGETED AGENTS


Click here to see Abstract details

 

ABSTRACTS & PRESENTATIONS

2022 ASCO ANNUAL MEETING - June 3-7, 2022 - McCormick Place, Chicago, IL - Hybrid Meeting

2022 ASCO Annual Meeting - Oral Abstract Session

Click here for details

 

Meeting: 2022 ASCO Annual Meeting - Session Type: Oral Abstract Session - Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia - Track: Hematologic Malignancies - Sub Track: Hematologic Malignancies - Clinical Trial Registration Number: NCT04557098

Abstract#: 8007 - Teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM): Updated efficacy and safety results from MajesTEC-1.


Click here to read abstract details

 

OAB-054 Comparative efficacy of teclistamab versus real-world physician’s choice of therapy in the prospective LocoMMotion study in patients with triple-class exposed relapsed/refractory multiple myeloma -Niels W.C.J. van de Donk


#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California

IMS 2022 Abstract EBook

https://www.myelomasociety.org/


#IMS2022 - 19th International Myeloma Society Annual Meeting; Aug 25-27, LA California (themyelomaclinicaltrials.com)

 

- New York: Memorial Sloan-Kettering Cancer Center New York

- New York: Tisch Cancer Institute Mount Sinai Hospital New York

- North Carolina: Levine Cancer Institute Charlotte

- Alabama: University of Alabama at Birmingham

- Michigan: Barbara Ann Karmanos Cancer Institute Detroit

 

Locations

United States, Alabama

United States, California

United States, Connecticut

United States, Florida

United States, Georgia

United States, Michigan

United States, New York

United States, North Carolina

United States, Ohio

United States, Pennsylvania


Canada, Alberta

Canada, Ontario

Canada, Quebec


Europe

United Kingdom

France

Germany

Italy

Netherlands

Spain

Sweden

Belgium

Asia

China

 

RELATED POSTS


TECLISTAMAB STUDIES:


NCT03145181: Phase 1 - Teclistamab, Humanized BCMA*CD3 Bispecific Ab, in Relapsed Myeloma (MajesTEC1)

Click here for details


NCT04557098: Phase 2- Teclistamab, in Participants With Relapsed or Refractory Myeloma (MajesTEC-1)

Click here for details


NCT05083169: Phase 3 - Tec-Dara Vs DPd Vs DVd in Relapsed or Refractory Myeloma - (MajesTEC-3)

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NCT05243797: Phase 3: Tec + Len Vs Len Alone in NDMM as Maintenance Therapy Post ASCT (MajesTEC-4)

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NCT04722146: Phase 1b - Teclistamab With Other Anticancer Therapies in Participants With Myeloma

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NCT05231629: Phase 2: Sequential Therapy in Multiple Myeloma Guided by MRD Assessments (MASTER-2)

Click here for details

 

TALQUETAMAB STUDIES:


NCT03399799: Phase 1 - Talquetamab, a Humanized GPRC5D x CD3 Bis Ab - Ref MM - MonumenTAL-1

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NCT04634552: Phase 2 - A Study of Talquetamab in Participants With Refractory Multiple Myeloma

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NCT05050097: Phase 1 - A Study of Talquetamab With Other Anticancer Therapies in Multiple Myeloma

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NCT04773522: Phase 1 - JNJ-64407564 in Japanese Participants With Relapsed or Refractory Myeloma

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TECLISTAMAB AND TALQUETAMAB STUDIES:


NCT04586426: Phase 1b - Talquetamab and Teclistamab in Relapsed or Refractory Multiple Myeloma

Click here for details


NCT04108195: Phase 1b - Subcutaneous Dara With Bispecific T Cell Redirection Antibodies - TRIMM-2

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