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

NCT ID: NCT04453397

Last Updated: 2021-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Interventions

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TNB-383B

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TeneoOne Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ben Buelow

Role: STUDY_CHAIR

Amgen

Locations

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Wake Forest

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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TNB383B.9001

Identifier Type: -

Identifier Source: org_study_id

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