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A Study of TNB-383B in Subjects With Relapsed or Refractory Multiple Myeloma

  • Clinicaltrials.gov identifier

    NCT03933735

  • Recruitment Status

    Recruiting

  • First Posted

    May 1, 2019

  • Last update posted

    December 19, 2020

Study Description

Brief summary:

This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, in subjects with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 2 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Arm A will evaluate the safety, tolerability, PK and PD profiles of escalating doses of single-agent TNB-383B, administered once every 3 weeks (Q3W), in approximately 85 subjects. Once the maximum tolerated dose (MTD) or recommended phase 2 dose, (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of the MTD/RP2D dose of TNB 383B monotherapy in approximately 48 subjects.

  • Condition or Disease:Multiple Myeloma
  • Intervention/Treatment: Drug: TNB-383B
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 133 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-383B, a Bispecific Antibody Targeting BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A: Dose Escalation
Up to 15 cohorts of subjects receiving sequentially ascending doses of TNB-383B are planned until maximum tolerated dose is reached or recommended phase 2 dose is identified.
Drug: TNB-383B
TNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells.
Experimental: Arm B: Dose Expansion
An expansion cohort will be enrolled after maximum tolerated dose or recommended phase 2 dose is established.
Drug: TNB-383B
TNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells.

Outcome Measures

  • Primary Outcome Measures: 1. Number of subjects with Dose-limiting toxicities (DLT) [ Time Frame: 21 days ]
  • 2. Number of subjects with adverse events (AEs) and/or serious adverse events (SAEs) [ Time Frame: From screening until 90 Days after end of treatment ]
    The incidence, timing, seriousness, and relationship to study treatments of adverse events will be evaluated. An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.
  • 3. Maximum Observed Plasma Concentration of TNB-383B (Cmax) [ Time Frame: 12 weeks ]
    Cmax of TNB-383B will be calculated
  • 4. Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) [ Time Frame: 12 weeks ]
    AUClast of TNB-383B will be calculated.
  • 5. Apparent terminal half-life (t1/2) of TNB-383B. [ Time Frame: 12 weeks ]
    t1/2 of TNB-383B will be calculated
  • Secondary Outcome Measures: 1. Incidence of Anti-drug Antibody (ADA) [ Time Frame: 48 months ]
    The number of participants with anti-TNB-383B antibodies
  • 2. Titers of Anti-drug Antibody (ADA) [ Time Frame: 48 months ]
    The titers of anti-TNB-383B antibodies
  • 3. Anti-Myeloma Activity by Objective Response Rate (ORR) [ Time Frame: 48 months ]
    The objective response rate, defined as the proportion of subjects with a confirmed partial (PR) or complete (CR) response to treatment as determined using International Myeloma Working Group (IMWG) uniform response criteria
  • 4. Anti-Myeloma Activity by Duration of Objective Response (DOR) [ Time Frame: 48 months ]
    Duration of objective response is measured as the time from the initial objective response to disease progression or death, whichever occurs first.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

- Subjects with Relapsed/Refractory Multiple Myeloma.

- Subject has received three or more prior lines of therapy with exposure to a
proteasome inhibitor (PI), an immunomodulatory imide (IMiD) and an anti-CD38
monoclonal antibody (e.g., daratumumab).

- Subject has Measurable Disease, 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 ( 1.65).

- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.

- Prior bone marrow transplant is acceptable if subject is > 12 weeks (autologous) or >
1 year (allogeneic) status-post transplantation

- Subject must have adequate bone marrow function, defined as:

- absolute neutrophil count (ANC) ≥ 1000/mm3;

- platelets ≥ 50,000/mm3;

- hemoglobin ≥ 8.0 g/dL.

- Subject must have an eGFR ≥ 30 mL/min as estimated by the MDRD formula.

- Subject must have total bilirubin ≤ 1.5 × upper limit of normal (ULN; except if the
subject has a known diagnosis of Gilbert's syndrome, in which case bilirubin must be < 3 x ULN). - Serum calcium (corrected for albumin) at or below the ULN range. Exclusion Criteria: - Subject has ever received BCMA-targeted therapy. Subjects who have received targeted therapy against non-BCMA targets will not be excluded - Subject has a history of central nervous system involvement by their myeloma. - Subject has a history of ≥ Grade 3 peripheral neuropathy. - Subject has a history of plasma cell leukemia, POEMS syndrome, or amyloidosis. - Subject has received any therapy to treat cancer or undergone a major surgical procedure within 21 days, or within 5 half-lives of an anticancer drug, prior to the first dose of study treatment, whichever is shorter. - Subject has a history of major cardiac abnormalities. - Subject has a known active infection requiring parenteral anti-infective treatment

Contacts and Locations

Contacts

Contact: Ben Buelow, MD, PhD (650) 899-8222 studydirector@teneobio.com

Locations

United States, California
UCSF
San Francisco

United States, Minnesota
Mayo Clinic-Rochester
Rochester

United States, Missouri
Washington University
Saint Louis

United States, North Carolina
Carolinas Healthcare
Charlotte

United States, North Carolina
Wake Forest
Winston-Salem

United States, Wisconsin
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee

Sponsors and Collaborators

Teneobio, Inc.

AbbVie

Investigators

Study Chair: Ben Buelow, MD, PhD Teneobio, Inc.

More Information

  • Responsible Party: Teneobio, Inc.
  • ClinicalTrials.gov Identifier: NCT03933735 History of Changes
  • Other Study ID Numbers: TNB383B.0001
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: December 19, 2020
  • Last Verified: December 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Neoplasms, Plasma Cell Multiple Myeloma