Phase
Condition
Follicular Lymphoma
Lymphoma, B-cell
Lymphoma
Treatment
AZD0486
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
Aged 18 to 80 years old
Histologically confirmed relapsed refractory FL (Module 1) and DLBCL (Module 2)after at least 2 prior lines of therapy
ECOG performance status 0 to 2
Locally confirmed CD-19 expression in lymphoma cells after progression fromlast CD 19 directed therapy
FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as > 1.5 cm in its longest dimension), or extranodal lesion (definedas > 1.0 cm in its longest dimension)
Adequate hematological function: ANC ≥ 1000/mm3, platelets
75,000/mm3, hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor areallowed but counts must be stable for at least 72 hours afterwards priorto screening
Adequate liver function: total bilirubin <1.5x ULN, AST/ALT ≤ 3xULN Note:Patients with documented history of Gilbert's Syndrome and in whom totalbilirubin elevations are accompanied by elevated indirect bilirubin areeligible)
Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min The above is a summary, other inclusion criteria details may apply.
Exclusion
- Key Exclusion Criteria:
Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
Active CNS involvement by B-NHL
Leukemic presentation of B-NHL
History or presence of clinically relevant CNS pathology such as epilepsy,seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson'sdisease, cerebellar disease, organic brain syndrome, or psychosis
Prior therapy with T-cell engager (TCE) within 8 weeks, CAR T- cell therapy orautologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, orprior allogeneic HSCT within 24 weeks of first dose of AZD0486
Requires chronic immunosuppressive therapy
Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
History of major cardiac abnormalities.
If female, participant must not be pregnant or breastfeeding.
The above is a summary, other exclusion criteria details may apply.
Study Design
Study Description
Connect with a study center
Research Site
Heidelberg, 3084
AustraliaActive - Recruiting
Research Site
Kogarah, NSW 2217
AustraliaSite Not Available
Research Site
Macquarie University, 2109
AustraliaActive - Recruiting
Research Site
Nedlands, 6009
AustraliaActive - Recruiting
Research Site
Porto Alegre, 90035903
BrazilSite Not Available
Research Site
Sao Paulo, 05652-900
BrazilSite Not Available
Research Site
Barrie, Ontario L4M 6M2
CanadaSite Not Available
Research Site
Brampton, Ontario L6R 3J7
CanadaActive - Recruiting
Research Site
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
Research Site
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Research Site
Chengdu, 610072
ChinaSite Not Available
Research Site
Guangzhou, 510060
ChinaSite Not Available
Research Site
Nanchang, 330029
ChinaSite Not Available
Research Site
Nanjing, 210029
ChinaSite Not Available
Research Site
Nantong, 226001
ChinaSite Not Available
Research Site
Shandong,
ChinaSite Not Available
Research Site
Shanghai, 200032
ChinaSite Not Available
Research Site
Tianjin, 300020
ChinaSite Not Available
Research Site
Zhengzhou, 450008
ChinaSite Not Available
Research Site
Aalborg, 9100
DenmarkSite Not Available
Research Site
Copenhagen, 2100
DenmarkSite Not Available
Research Site
Vejle, 7100
DenmarkSite Not Available
Research Site
Montpellier, 34295
FranceSite Not Available
Research Site
Paris, 75010
FranceSite Not Available
Research Site
Pierre Bénite, 69495
FranceSite Not Available
Research Site
Rouen Cedex 1, 76038
FranceSite Not Available
Research Site
Berlin, 10967
GermanySite Not Available
Research Site
Chemnitz, 9116
GermanySite Not Available
Research Site
Essen, 45147
GermanySite Not Available
Research Site
Jena, 07747
GermanySite Not Available
Research Site
Wuerzburg, 97080
GermanySite Not Available
Research Site
Hong Kong, 999077
Hong KongSite Not Available
Research Site
Shatin, 00000
Hong KongSite Not Available
Research Site
Alessandria, 15121
ItalySite Not Available
Research Site
Bologna, 40138
ItalySite Not Available
Research Site
Busto Arsizio, 21052
ItalySite Not Available
Research Site
Milan, 20141
ItalySite Not Available
Research Site
Milano, 20132
ItalySite Not Available
Research Site
Roma, 161
ItalySite Not Available
Research Site
Chiba-shi, 260-8717
JapanActive - Recruiting
Research Site
Kashiwa, 277-8577
JapanSite Not Available
Research Site
Koto-ku, 135-8550
JapanActive - Recruiting
Research Site
Kumamoto-shi, 860-0008
JapanActive - Recruiting
Research Site
Niigata-shi, 951-8520
JapanActive - Recruiting
Research Site
Okayama-shi, 700-8558
JapanActive - Recruiting
Research Site
Osaka-shi, 541-8567
JapanActive - Recruiting
Research Site
Yokohama-shi, 241-8515
JapanActive - Recruiting
Research Site
Seoul, 3722
Korea, Republic ofSite Not Available
Research Site
Barcelona, 8035
SpainSite Not Available
Research Site
Madrid, 28040
SpainSite Not Available
Research Site
Pozuelo de Alarcon, 28223
SpainSite Not Available
Research Site
Goteborg, 41345
SwedenSite Not Available
Research Site
Stockholm, 17176
SwedenSite Not Available
Research Site
Kaohsiung, 80756
TaiwanSite Not Available
Research Site
Kaohsiung City, 833401
TaiwanActive - Recruiting
Research Site
Taichung, 404
TaiwanSite Not Available
Research Site
Tainan City, 70403
TaiwanActive - Recruiting
Research Site
Taipei City, 106
TaiwanActive - Recruiting
Research Site
Manchester, M20 4BX
United KingdomSite Not Available
Research Site
Norwich, NR4 7UY
United KingdomSite Not Available
Research Site
Nottingham, NG5 1PB
United KingdomSite Not Available
Research Site
Duarte, California 91010
United StatesSite Not Available
Research Site
Tampa, Florida 33612
United StatesSite Not Available
Research Site
Des Moines, Iowa 50314
United StatesSite Not Available
Research Site
Overland Park, Kansas 66204
United StatesSite Not Available
Research Site
Rochester, Minnesota 55905
United StatesSite Not Available
Research Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Research Site
New Brunswick, New Jersey 08901
United StatesSite Not Available
Research Site
New York, New York 10016
United StatesSite Not Available
Research Site
Charlotte, North Carolina 28203
United StatesSite Not Available
Research Site
Columbus, Ohio 43210
United StatesSite Not Available
Research Site
Portland, Oregon 97239
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Research Site
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Research Site
Houston, Texas 77030
United StatesSite Not Available
Research Site
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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