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:

  AZD0486 (); TNB-486 ()

• Inclusion Criteria

  • Biopsy proven B-NHL, including DLBCL, HGBL, or FL. -. In order to be eligible for this study subjects must not be candidates for treatment regimens known to provide clinical benefit in B-NHL. CAR T-naive subjects are allowed if they have declined, are considered ineligible for, or do not have timely access to CAR T cell therapies.
  • Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
  • Must have adequate liver, bone marrow and kidney function (eGFR ≥ 50 mL/min).
  • Must have locally confirmed CD19 positivity (must be documented after time of progression from last CD19-targeted therapy, if received)
  • Must have at least 1 measurable disease site
  • Must have ANC >/= 1000/mm3, platelets >/= 50,000 mm3, hemoglobin >/= 8.0 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening
  • Must have a total bilirubin <1.5x uln ast alt>< 3xULN

• Exclusion Criteria

  • Has been diagnosed with or treated for another malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
  • Has active central nervous system (CNS) involvement by their B-NHL. Subjects may be eligible with a distant history of CNS involvement that has been adequately treated with no evidence of recurrence within last 6 months from screening.
  • Has a 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.
  • Received CD19 CAR T therapy within 3 months prior to first dose.
  • Experienced Grade > 3 cytokine release syndrome (CRS) following prior T-cell engager (TCE) or CAR T-cell therapy.
  • Experienced Grade > 2 neurotoxicity/immune effector cell-associated neurotoxicity syndrome (ICANS) following prior TCE or CAR T-cell therapy.
  • Has 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.
  • Participant with human immunodeficiency virus (HIV) infection, or subjects 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. Participant with chronic HBV may be enrolled if the HBV viral load is undetectable on suppressive therapy, or if the participant has a documented cure. Participant 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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