Back to resultsExpanded Access for TNB-383B in a Subject With Relapsed/Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
TNB-383B
Sponsored by
About this trial
This is an expanded access trial for Multiple Myeloma
Eligibility 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
Sites / Locations
- Wake Forest
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04453397
Brief Title
Expanded Access for TNB-383B in a Subject With Relapsed/Refractory Multiple Myeloma
Official Title
A Single Patient Protocol for TNB-383B, a Bispecific Antibody Targeting BCMA in a Subject With Relapsed/Refractory Multiple Myeloma
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TeneoOne Inc.
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TNB-383B
Intervention Description
TNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Buelow
Organizational Affiliation
Amgen
Official's Role
Study Chair
Facility Information:
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Expanded Access for TNB-383B in a Subject With Relapsed/Refractory Multiple Myeloma
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