- Recruiting
NCT03145181: Phase 1 - Teclistamab, Humanized BCMA*CD3 Bispecific Ab, in Relapsed Myeloma MajesTEC1
Updated: Sep 15, 2022
MajesTEC1
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1)
Relapsed & Refractory Multiple Myeloma
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.
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1)
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
Sponsor
Multiple Locations
International Study
ClinicalTrials.gov Identifier: NCT03145181
Official Title: 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
First Posted : May 9, 2017
Cick here to see details on Clinicaltrials.gov
Drug: Teclistamab (IV)
Drug: Teclistamab(SC)
JNJ 64007957
A bispecific humanized monoclonal antibody against human CD3, a T-cell surface antigen, and human B-cell maturation antigen (BCMA; TNFRSF17)
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.
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.
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
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.
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
ABSTRACTS & PRESENTATIONS
2022 ASCO ANNUAL MEETING - June 3-7, 2022 - McCormick Place, Chicago, IL - Hybrid Meeting
2022 ASCO Annual Meeting - Oral Abstract Session
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.
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
- California: City of Hope Duarte
- New York: Tisch Cancer Institute Mount Sinai Hospital New York
- North Carolina: Levine Cancer Institute Charlotte
- Pennsylvania: University of Pennsylvania Philadelphia
Locations
United States, California
United States, New York
United States, North Carolina
United States, Pennsylvania
Europe
France
Netherlands
Spain
Sweden
RELATED POSTS
TECLISTAMAB STUDIES:
NCT03145181: Phase 1 - Teclistamab, Humanized BCMA*CD3 Bispecific Ab, in Relapsed Myeloma (MajesTEC1)
NCT04557098: Phase 2- Teclistamab, in Participants With Relapsed or Refractory Myeloma (MajesTEC-1)
NCT05083169: Phase 3 - Tec-Dara Vs DPd Vs DVd in Relapsed or Refractory Myeloma - (MajesTEC-3)
NCT05243797: Phase 3: Tec + Len Vs Len Alone in NDMM as Maintenance Therapy Post ASCT (MajesTEC-4)
NCT04722146: Phase 1b - Teclistamab With Other Anticancer Therapies in Participants With Myeloma
NCT05231629: Phase 2: Sequential Therapy in Multiple Myeloma Guided by MRD Assessments (MASTER-2)
TALQUETAMAB STUDIES:
NCT03399799: Phase 1 - Talquetamab, a Humanized GPRC5D x CD3 Bis Ab - Ref MM - MonumenTAL-1
NCT04634552: Phase 2 - A Study of Talquetamab in Participants With Refractory Multiple Myeloma
NCT05050097: Phase 1 - A Study of Talquetamab With Other Anticancer Therapies in Multiple Myeloma
NCT04773522: Phase 1 - JNJ-64407564 in Japanese Participants With Relapsed or Refractory Myeloma
TECLISTAMAB AND TALQUETAMAB STUDIES:
NCT04586426: Phase 1b - Talquetamab and Teclistamab in Relapsed or Refractory Multiple Myeloma
NCT04108195: Phase 1b - Subcutaneous Dara With Bispecific T Cell Redirection Antibodies - TRIMM-2
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