Clinical Trial 21122

• Overview

  Study Title:

  A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AZD0486, 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 AZD0486 when administered as monotherapy; 2. Determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for AZD0486 when administered as monotherapy; 3. Evaluate the clinical pharmacology (i.e., pharmacokinetics) of AZD0486 when administered as monotherapy; 4. Evaluate the clinical activity of AZD0486 when administered as monotherapy.

• Treatments

  Therapies:

  Immunotherapy; Therapy (NOS)

  Medications:

  TNB-486 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Participant between 18 and 80 years of age at the time of signing the Informed Consent. Participants greater than 80 years of age may enroll in cohorts 5d and 6d.
  • 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 less than or equal to 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
  • Has history or presence of clinically significant CNS pathology
  • Has CNS involvement from active or history of autoimmune disease
  • Has experienced Grade > 3 CRS (based on ASTCT criteria) following prior TCE or CAR T-cell therapy
  • Has experienced Grade > 2 neurotoxicity/ICANS (based on ASTCT criteria) following prior TCE or CAR T-cell therapy
  • 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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