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

Overview

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.

Full Title of Study: “A Single Patient Protocol for TNB-383B, a Bispecific Antibody Targeting BCMA in a Subject With Relapsed/Refractory Multiple Myeloma”

Study Type

• Study Type: Expanded Access

Interventions

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

• Lead Sponsor
  • TeneoOne Inc.
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Ben Buelow, Study Chair, Amgen