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RecruitingLast updated: 8 March 2024

TNB486.001: This study is investigating how safe, tolerable and effective a new immunotherapy is in people with relapsed or refractory B-cell non-Hodgkin lymphoma who have had prior treatmentA 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

Clinical summary

Summary

This study consists of three parts: Dose Optimisation Arm A, Experimental Arm B, Experimental Arm C.

Dose Optimisation Arm A: The first part of the study is seeking to determine the optimal dose of a new antibody drug (called AZD0486). Eligible participants will be enrolled into cohorts of incrementally increasing doses of AZD0486 administered intravenously on day 1 and 15 of 28 day cycles for a maximum of 24 cycles or until disease progression.

Experimental Arm B: Participants with biopsy proven diffuse large B-cell lymphoma or high-grade B-cell lymphoma will receive a dose expansion of drug AZD0486 intravenously.

Experimental Arm C: Participants with biopsy proven follicular lymphoma will receive a dose expansion of drug AZD0486 intravenously.

The expansion dose and dosing frequency for Arm B and Arm C will be chosen based on safety, tolerability, and data collected during the dose escalation portion of the study.

Conditions

This trial is treating patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Cancer

Blood Cancers Haematological

Age

People18 - 130

Phase

I

Trial Acronym

TNB486.001

More information

Trial Identifiers

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Trial sponsor

AstraZeneca; Teneo Two, Inc.

Scientific 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

Eligibility

Inclusion

  • Biopsy proven B-NHL, including DLBCL, HGBL, or FL.
  • For Arm B Only: Subject has biopsy proven DLBCL or HGBL
  • For Arm C only: Subject has biopsy proven FL
  • Subject 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 subjects must not be candidates for treatment regimens known to provide clinical benefit in B-NHL.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
  • Subject must have adequate liver, bone marrow and kidney function (eGFR ≥ 50 mL/min).
  • Subject must have locally confirmed CD19 positivity (must be documented after time of progression from last CD19-targeted therapy, if received)
  • Subject must have at least 1 measurable disease site
  • Subject 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
  • Subject must have a total bilirubin <1.5x ULN, AST/ALT < 3xULN

Exclusion

  • Subject 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.
  • Subject has a history of central nervous system (CNS) involvement by their B-NHL
  • Subject has a history of leukemic presentation of their B-NHL.
  • Subject has history or presence of clinically significant CNS pathology
  • Subject has CNS involvement from active or history of autoimmune disease.
  • Subject experienced Grade ≥ 3 cytokine release syndrome (CRS) following prior T-cell engager (TCE) or CAR T-cell therapy.
  • Subject experienced Grade ≥ 2 neurotoxicity/immune effector cell-associated neurotoxicity syndrome (ICANS) following prior TCE or CAR T-cell therapy.
  • Subject 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.
  • Subjects 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. Subjects 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.
  • Subject has a history of major cardiac abnormalities.
  • If female, subject must not be pregnant or breastfeeding

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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