Phase
Condition
Follicular Lymphoma
Lymphoma, B-cell
Lymphoma
Treatment
AZD0486 IV
Clinical Study ID
Ages 18-130 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Biopsy proven B-NHL, including DLBCL, HGBL, or FL.
-. In order to be eligible for this study subjects must not be candidates fortreatment regimens known to provide clinical benefit in B-NHL. CAR T-naive subjectsare allowed if they have declined, are considered ineligible for, or do not havetimely access to CAR T cell therapies.
Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
Subject must have adequate liver, bone marrow and kidney function (eGFR ≥ 50mL/min).
Subject must have locally confirmed CD19 positivity (must be documented after timeof 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 >/= 8.0g/dL. Transfusion and/or growth factor are allowed but counts must be stable for atleast 72 hours afterwards prior to screening
Subject must have a total bilirubin <1.5x ULN, AST/ALT < 3xULN
Exclusion
Exclusion Criteria:
Subject has been diagnosed with or treated for another malignancy whose naturalhistory or treatment may interfere with the safety or efficacy assessment of theinvestigational regimen.
Subject has active central nervous system (CNS) involvement by their B-NHL. Subjectsmay be eligible with a distant history of CNS involvement that has been adequatelytreated with no evidence of recurrence within last 6 months from screening.
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 received CD19 CAR T therapy within 3 months prior to first dose.
Subject experienced Grade ≥ 3 cytokine release syndrome (CRS) following prior T-cellengager (TCE) or CAR T-cell therapy.
Subject experienced Grade ≥ 2 neurotoxicity/immune effector cell-associatedneurotoxicity syndrome (ICANS) following prior TCE or CAR T-cell therapy.
Subject has received a peripheral autologous stem cell transplant (SCT) within 12weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatmentor has received an SCT and requires ongoing immunosuppressive therapy.
Subjects with human immunodeficiency virus (HIV) infection, or subjects with chronicor active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).HIV-infected patients on effective anti-retroviral therapy with undetectable viralload within 6 months are eligible for this trial. Subjects with chronic HBV may beenrolled if the HBV viral load is undetectable on suppressive therapy, or if thesubject has a documented cure. Subjects with HCV who have a documented cure may beenrolled.
Subject has a history of major cardiac abnormalities.
If female, subject must not be pregnant or breastfeeding.
Study Design
Study Description
Connect with a study center
Research Site
Bedford Park, 5042
AustraliaSite Not Available
Research Site
Heidelberg, 3084
AustraliaActive - Recruiting
Research Site
Hobart, 7000
AustraliaActive - Recruiting
Research Site
Melbourne, 3004
AustraliaActive - Recruiting
Research Site
Chuo-ku, 104-0045
JapanActive - Recruiting
Research Site
Koto-ku, 135-8550
JapanActive - Recruiting
Research Site
Nagoya-shi, 460-0001
JapanActive - Recruiting
Research Site
Yamagata-shi, 990-9585
JapanActive - Recruiting
Asan Medical Center
Seoul, 5505
Korea, Republic ofActive - Recruiting
Research Site
Seoul, 03080
Korea, Republic ofActive - Recruiting
Seoul St Mary's Hospital
Seoul, 6591
Korea, Republic ofActive - Recruiting
Severance hospital, Yonsei University
Seoul, 3722
Korea, Republic ofActive - Recruiting
Research Site
Kaohsiung City, 833401
TaiwanActive - Recruiting
Research Site
Kweishan, 333
TaiwanActive - Recruiting
Research Site
Tainan, 704
TaiwanActive - Recruiting
Research Site
Taipei, 10002
TaiwanActive - Recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United StatesActive - Recruiting
Research Site
Tampa, Florida 33612
United StatesActive - Recruiting
Norton Cancer Institute
Louisville, Kentucky 40207
United StatesActive - Recruiting
Research Site
Louisville, Kentucky 40207
United StatesActive - Recruiting
Research Site
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Levine Cancer Institute/Atrium Health Charlotte NC
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Research Site
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Research Site
Columbus, Ohio 43210
United StatesActive - Recruiting
Research Site
Portland, Oregon 97239
United StatesSite Not Available
Research Site
Pittsburgh, Pennsylvania 15237
United StatesActive - Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Research Site
Austin, Texas 78704
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
Research Site
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.