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Clinical Trial 21122

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04594642

Phase: Phase I
Principal Investigator: Gaballa, Sameh

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Overview

Study Title

A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-486, a Bispecific Antibody Targeting CD19 in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Summary

This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) who have received 2 or more prior lines of therapy

Objective

1. Evaluate the safety and tolerability of TNB-486 when administered as monotherapy; 2. Determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for TNB-486 when administered as monotherapy; 3. Evaluate the clinical pharmacology (i.e., pharmacokinetics) of TNB-486 when administered as monotherapy; 4. Evaluate the clinical activity of TNB-486 when administered as monotherapy.

Treatments

Therapies

Immunotherapy; Therapy (NOS)

Medications

TNB-486 ()

Inclusion Criteria

Inclusion Criteria:

  • Biopsy proven B-NHL, including DLBCL, HGBL, transformed indolent NHL including Richter's transformation, mantle cell lymphoma (MCL), FL, or marginal zone lymphoma (MZL).
  • For Arm B Only: Subject has biopsy proven DLBCL or HGBL
  • For Arm C only: Subject has biopsy proven FL
  • Has received at least 2 lines of therapy to which the subject has been either refractory or has subsequently relapsed. In order to be eligible for this study patients must not be candidates for treatment regimens known to provide clinical benefit in B-NHL.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
  • Must have adequate liver, bone marrow and kidney function (eGFR >/= 50 mL/min).

  • Exclusion Criteria

    Exclusion Criteria:

  • Diagnosed with or treated for another malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
  • History of central nervous system (CNS) involvement by their B-NHL
  • History of leukemic presentation of their B-NHL, with the exception of MCL or MZL.
  • Clinically significant CNS pathology
  • Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatment or has received an SCT and requires ongoing immunosuppressive therapy.
  • Patients with human immunodeficiency virus (HIV) infection, or patients with chronic or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients with chronic HBV may be enrolled if the HBV viral load is undetectable on suppressive therapy, or if the subject has a documented cure. Subjects with HCV who have a documented cure may be enrolled.
  • History of major cardiac abnormalities.
  • If female, must not be pregnant or breastfeeding.

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