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NCT04453397 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04453397
Other study ID # TNB383B.9001
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date September 2021
Source TeneoOne Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Wake Forest Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
TeneoOne Inc.

Country where clinical trial is conducted

United States, 

See also
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