We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Expanded Access for TNB-383B in a Subject With Relapsed/Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04453397
Expanded Access Status : No longer available
First Posted : July 1, 2020
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
TeneoOne Inc.

Study Description
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a single patient protocol for TNB-383B in a subject with relapsed/refractory multiple myeloma (MM) who is not a candidate for treatment regimens known to provide clinical benefit in MM.

Condition or disease Intervention/treatment
Multiple Myeloma Drug: TNB-383B

Study Design
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: A Single Patient Protocol for TNB-383B, a Bispecific Antibody Targeting BCMA in a Subject With Relapsed/Refractory Multiple Myeloma

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Interventions
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: TNB-383B
    TNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells.
Eligibility Criteria
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Adequate bone marrow function
  • eGFR ≥ 30 mL/min
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • Serum calcium (corrected for albumin) at or below the ULN range

Exclusion Criteria:

  • Candidate for treatment regimens known to provide clinical benefit in MM
  • Active infection requiring parenteral anti-infective treatment
  • Any medical or psychiatric condition which in the opinion of the investigator or Teneobio Medical Monitor places the subject at an unacceptably high risk for toxicities, could interfere with successful or safe delivery of therapy, or could interfere with evaluation of the investigational product or interpretation of subject safety
Contacts and Locations
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04453397


Locations
Layout table for location information
United States, North Carolina
Wake Forest
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
TeneoOne Inc.
Investigators
Layout table for investigator information
Study Chair: Ben Buelow Amgen
More Information
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: TeneoOne Inc.
ClinicalTrials.gov Identifier: NCT04453397    
Other Study ID Numbers: TNB383B.9001
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases