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

TeneoOne

Status

Conditions: Multiple Myeloma

Treatments: Drug: TNB-383B

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04453397

TNB383B.9001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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