A Multi-center, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-383B

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Overview

TNB-383B is a bi-specific antibody, meaning that it interacts with two molecules in your body. One molecule is called B-Cell Maturation Antigen (BCMA) and is found on your multiple myeloma cells. The second is called CD3 and is present on your killer T-cells. When CD3 is engaged on a T cell, it turns the T-cell on and makes it kill whatever cell triggered the activation. Because TNB-383B sticks very strongly to the BCMA on your myeloma cells, nearby T-cells should specifically attack your tumor cells.

This study is open-label, meaning that everyone on the study will receive TNB-383B. It is a Phase 1, First-in-Human trial, meaning that it is the first study where TNB-383B will be given to human patients. TNB-383B is an investigational agent, meaning that it is still being tested for safety and efficacy and has not yet been approved by the FDA.

The purpose of the Study is:

  • To find the highest dose of TNB-383B that can be given without causing severe side effects.
  • To find out the side effects seen when giving TNB-383B at different doses.
  • To gather early information about how well TNB-383B treats myeloma.
  • To measure the amount of TNB-383B in the blood at different doses.
  • To evaluate biomarkers in your blood or at relevant disease site(s). A biomarker is a substance in your blood or at relevant disease site(s) that may indicate how your disease is progressing or how effective a certain treatment is.
SparkCures ID 998
Trial Phase Phase 1
Enrollment 133 Patients
Treatments
Tags
Trial Sponsors
  • Teneobio Inc.
NCT Identifier

NCT03933735

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

You may be eligible to participate in this study if you:

  • Are at least 18 years old.
  • Have Relapsed or refractory multiple myeloma
  • Have had three or more prior lines of therapy with exposure to a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 antibody (ie, daratumumab).
  • Have measurable disease is defined as at least 1 of the following:
    • Serum M-protein ≥ 0.5 g/dL (≥ 5 g/L)
    • Urine M-protein ≥ 200 mg / 24h
    • Serum free light chain (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/L) and an abnormal serum FLC ratio (< 0.26 or > 1.65).
  • Do not have a history of plasma cell leukemia, POEMS syndrome, or amyloidosis
  • Do not a history of central nervous system (CNS) involvement by your myeloma
  • Have not received a prior BCMA-targeted therapy

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

California
Minnesota
Mayo Clinic (Rochester)
Mayo Clinic (Rochester)

Rochester, MN

Missouri
North Carolina
Levine Cancer Institute Atrium Health
Wisconsin
Medical College of Wisconsin Froedtert Hospital

Published Results

Off-the-Shelf BCMA-Targeted Therapy TNB-383B Shows Early Safety, Efficacy in Relapsed/Refractory Myeloma

December 06, 2020

A novel BCMA and CD3 targeted bispecific T-cell engaging immunotherapy agent TNB-383B has demonstrated significant responses at higher dose levels and tolerability at all dose levels, including mild cases of cytokine release syndrome (CRS), according to initial results of a phase 1 trial (NCT03933735) presented during the 2020 American Society of Hematology (ASH) Annual Meeting.

...

CRS was the most common adverse event (AE) reported on the study and was observed in 45% of patients at any grade, which increased to 80% in patients who received doses ≥40 mg, but cases were grade 1/2. The median onset to CRS was less than a day (range, 0-7) and the median duration was 1 day (range, 1-7). Five patients were treated with tocilizumab. Only 1 patient had a reoccurrence of CRS.

Other common AEs included fatigue (24%), headache (22%), infection (21%), nausea (21%), and anemia (21%). The most common grade ≥3 AEs were anemia (17%), neutropenia (16%), thrombocytopenia (14%), and infection (14%). Treatment-related AEs increased at higher doses ≥40 mg due to increased CRS, but there was no significant increase observed in the incidence of other AEs with higher doses of treatment.

...

The objective response rate (ORR) at lower doses (0.025 to 1.8 mg; n = 15) was 20%, with a complete response (CR) rate or better of 6.7%. At doses from 5.4 to 30 mg (n = 28), the ORR was 43% with a CR or better rate of 17.9%. The ORR was 80% at higher dose levels (40 to 60 mg; n = 15) with a CR or better rate of 13.3%. Three of 4 patients evaluable for minimal residual disease were found to be negative.

Resources

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