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

Updated: Sep 16

Talquetamab and Teclistamab

Daratumumab


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

Talquetamab-Teclistamab-Daratumumab

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


The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and schedule for the study treatment (Part 1) and to characterize the safety of the RP2R(s) for the study treatment (Part 2). The RP2R(s) will describe the combination doses and schedules of (tal+tec+dara) the treatment combinations to be pursued in Phase 2.


Sponsor

Janssen Research & Development, LLC

 

ClinicalTrials.gov Identifier: NCT04586426

Official Title: A Phase 1b Dose Escalation Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

First Posted : October 14, 2020

Click here to see details on ClinicalTrials.gov


A Study of the Combination of Talquetamab and Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma | Global Trial Finder (janssen.com)

 

JNJ 64007957 - Teclistamab

JNJ-64407564 - Talquetamab

daratumumab and hyaluronidase-fihj: National Cancer Institute

daratumumab and hyaluronidase-fihj: MedlinePlus Drug Information

 

Talquetamab is a humanized IgG4PAA bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell).


Teclistamab is a humanized IgG4PAA bispecific antibody designed to target B cell maturation antigen (BCMA) and the CD3 molecule found on T cells.


Daratumumab is a human IgG1ĸ monoclonal antibody that binds with high affinity to a unique epitope on cluster of differentiation 38 (CD38) in a variety of hematological malignancies including multiple myeloma

 

Teclistamab

Anti-CD3/Anti-BCMA Bispecific Monoclonal Antibody JNJ-64007957

A bispecific humanized monoclonal antibody against human CD3, a T-cell surface antigen, and human B-cell maturation antigen (BCMA; TNFRSF17)

 

Talquetamab

anti-CD3/anti-GPRC5D bispecific monoclonal antibody JNJ-64407564

A bispecific humanized monoclonal antibody against human CD3, a T-cell surface antigen, and human G-protein coupled receptor family C group 5 member D (GPRC5D), a tumor-associated antigen (TAA), with potential antineoplastic activity.

GPRC5D x CD3 bispecific antibody JNJ-64407564

GPRC5D x CD3 DuoBody antibody JNJ-64407564

GPRC5D/CD3 DuoBody antibody JNJ-64407564

humanized GPRC5D x CD3 DuoBody antibody JNJ-64407564

 

Daratumumab

Anti-CD38_Monoclonal_Antibody

A fully human monoclonal antibody directed against the cell surface glycoprotein CD-38 with potential antineoplastic activity. The binding of daratumumab to natural killer (NK) cells mimics the normal CD38-CD31 interaction on the NK cell surface.

JNJ-54767414

Darzalex


Daratumumab and hyaluronidase-fihj

DARA Co-formulated with rHuPH20

A co-formulation composed of daratumumab, a human immunoglobulin (Ig) G1 kappa monoclonal antibody directed against the cell surface glycoprotein cluster of differentiation 38 (CD-38; CD38), and a recombinant form of human hyaluronidase (rHuPH20), with potential antineoplastic activity.

DARA/rHuPH20

daratumumab + rHuPH20

daratumumab with rHuPH20

daratumumab-rHuPH20

daratumumab/rHuPH20 co-formulation

darzalex/rHuPH20

HuMax-CD38-rHuPH20

recombinant human hyaluronidase mixed with daratumumab

Darzalex Faspro

 

- Multiple locations

- International Study

 

Locations

Canada, Alberta

Canada, Quebec


Europe

Spain

Asia

Israel

Korea, Republic of

 

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TALQUETAMAB STUDIES:


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TECLISTAMAB AND TALQUETAMAB STUDIES:


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

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