Clincosm LogoSign in Get a demo

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

Sponsor
TeneoOne Inc. (Industry)
Overall Status
No longer available
CT.gov ID
NCT04453397
Collaborator
(none)
1
Location

Study Details

Study Description

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 Phase

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Wake Forest Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • TeneoOne Inc.

    Investigators

    • Study Chair: Ben Buelow, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TeneoOne Inc.
    ClinicalTrials.gov Identifier:
    NCT04453397
    Other Study ID Numbers:
    • TNB383B.9001
    First Posted:
    Jul 1, 2020
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Sep 23, 2021