Clinical Trials List
Protocol NumberD7400C00006
NCT Number(ClinicalTrials.gov Identfier)NCT04594642
2023-10-20 - 2026-12-31
Phase I
Recruiting4
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
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Trial Applicant
Syneos Health
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- HSIN-AN HOU Division of Hematology & Oncology
- CHENG-HONG TSAI Division of Hematology & Oncology
- MING YAO Division of Hematology & Oncology
- 田豐銘 Division of Hematology & Oncology
- Chieh-Lung Cheng Division of Hematology & Oncology
- Tai-Chung Huang Division of Hematology & Oncology
- Huai-Hsuan Huang Division of Hematology & Oncology
- - - Division of Hematology & Oncology
- Chien-Chin Lin Division of Hematology & Oncology
- 林明恩 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- HSUAN JEN SHIH Division of Hematology & Oncology
- Ming-Chung Kao Division of Hematology & Oncology
- Tung-Liang Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 傅蓓安 無
- Ya-Ping Chen 無
- Ya-Ting Hsu 無
- 顏志傑 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
B-cell Non Hodgkin Lymphoma、 Diffuse Large B Cell Lymphoma 、High-grade B-cell Lymphoma、 Follicular Lymphoma
Objectives
main:
‧ To assess the safety and tolerability of AZD0486 as monotherapy
‧ Confirm the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD0486 as monotherapy.
‧ To evaluate the pharmacokinetics (PK) of AZD0486 as monotherapy.
secondary:
‧ To evaluate the clinical activity of AZD0486 as monotherapy.
‧ Evaluate the anti-drug antibody potency of AZD0486 as monotherapy.
Exploratory:
‧ Evaluate pharmacodynamics and exploratory biomarkers and evaluate their correlation with safety, pharmacokinetics and clinical activity.
Test Drug
AZD0486
Active Ingredient
AZD0486
Dosage Form
Concentration for Solution for Infusion
Dosage
2 mg/mL
Endpoints
Assessment of dosing regimen:
Part 1 (Group A) and Part 2 (Groups B and C)
Trial visits and assessments will occur during the screening period and on days 1, 8, and 15 of each cycle according to the event schedule. Based on the 4-week cycle, additional trial visits and evaluations will occur on Days 2, 3, 8, 9, 10, 15, 16, 17, and 22 of Cycle 1, and Day 2 of Cycle 6.
Assessments will be conducted before all trial drugs are administered, at end-of-treatment (EOT) follow-up visits (within 30 days after the last dose of trial medication) and 90 (± 7) days after the last dose of trial medication, including physical examination, hematology and chemical testing. . A positron tomography-computed tomography (PET-CT) scan will be performed on day 1 of every three cycles. If the subject has a history of bone marrow invasive disease, bone marrow sectioning and aspiration should be performed whenever possible to confirm any CR and to assess minimal residual disease (MRD) in subjects who achieve an objective response. Adverse events, concomitant medications, laboratory data and vital signs will be assessed throughout the trial. In addition, subjects will be contacted every 12 weeks to collect survival data.
Part 1 (Group A) and Part 2 (Groups B and C)
Trial visits and assessments will occur during the screening period and on days 1, 8, and 15 of each cycle according to the event schedule. Based on the 4-week cycle, additional trial visits and evaluations will occur on Days 2, 3, 8, 9, 10, 15, 16, 17, and 22 of Cycle 1, and Day 2 of Cycle 6.
Assessments will be conducted before all trial drugs are administered, at end-of-treatment (EOT) follow-up visits (within 30 days after the last dose of trial medication) and 90 (± 7) days after the last dose of trial medication, including physical examination, hematology and chemical testing. . A positron tomography-computed tomography (PET-CT) scan will be performed on day 1 of every three cycles. If the subject has a history of bone marrow invasive disease, bone marrow sectioning and aspiration should be performed whenever possible to confirm any CR and to assess minimal residual disease (MRD) in subjects who achieve an objective response. Adverse events, concomitant medications, laboratory data and vital signs will be assessed throughout the trial. In addition, subjects will be contacted every 12 weeks to collect survival data.
Inclution Criteria
Inclusion Criteria:
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
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 Criteria
Exclusion Criteria:
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.
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.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
231 participants
