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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.

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

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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



Intervention Details:
  • Drug: TNB-383B
    TNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells.

Information from the National Library of Medicine

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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

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
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United States, North Carolina
Wake Forest
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
TeneoOne Inc.
Investigators
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Study Chair: Ben Buelow Amgen
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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:
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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