Phase
Condition
Lymphoma
Follicular Lymphoma
Lymphoma, B-cell
Treatment
AZD0486
Surovatamig
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
Aged 18 years old and above
Histologically confirmed relapsed refractory FL (Module 1) and LBCL (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 or < 5 ×ULN in the presence of lymphoma involvement of the liver
Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min
Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA 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 of a clinically relevant CNS medical condition or pathology thatrequired treatment in the preceding year, is currently symptomatic, or that thetreating investigator considers to have the potential to interfere with theevaluation of safety, such as epilepsy, seizure, paresis, aphasia, stroke,severe brain injuries, dementia, neurodegenerative disorder includingParkinson's disease, cerebellar disease, organic brain syndrome, psychosis orother severe mental illness.
Prior therapy with T-cell engager (TCE) within 8 weeks, autologousHematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, CAR T- celltherapy within 6 months, or prior allogeneic HSCT within 24 weeks of first doseof surovatamig
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
AustraliaActive - Recruiting
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
BrazilActive - Recruiting
Research Site
São Paulo, 01401-002
BrazilActive - Recruiting
Research Site
São Paulo 3448439, 05652-900
BrazilActive - Recruiting
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
CanadaActive - Recruiting
Research Site
Chengdu, 610041
ChinaActive - Recruiting
Research Site
Chengdu 1815286, 610072
ChinaActive - Recruiting
Research Site
Guangzhou, 510060
ChinaActive - Recruiting
Research Site
Nanchang, 330029
ChinaActive - Recruiting
Research Site
Nanjing, 210029
ChinaActive - Recruiting
Research Site
Nantong, 226001
ChinaActive - Recruiting
Research Site
Shandong,
ChinaActive - Recruiting
Research Site
Shanghai, 200032
ChinaActive - Recruiting
Research Site
Shanghai 1796236, 200025
ChinaSite Not Available
Research Site
Tianjin, 300020
ChinaActive - Recruiting
Research Site
Zhengzhou, 450008
ChinaActive - Recruiting
Research Site
Aalborg, 9100
DenmarkSite Not Available
Research Site
Copenhagen, 2100
DenmarkActive - Recruiting
Research Site
Vejle, 7100
DenmarkActive - Recruiting
Research Site
Montpellier, 34295
FranceActive - Recruiting
Research Site
Paris, 75010
FranceActive - Recruiting
Research Site
Pierre-Bénite, 69495
FranceActive - Recruiting
Research Site
Rouen, 76038
FranceActive - Recruiting
Research Site
Berlin, 10967
GermanyActive - Recruiting
Research Site
Chemnitz, 9116
GermanyActive - Recruiting
Research Site
Essen, 45147
GermanyActive - Recruiting
Research Site
Jena, 07747
GermanyActive - Recruiting
Research Site
Würzburg, 97080
GermanyActive - Recruiting
Research Site
Hong Kong, 999077
Hong KongActive - Recruiting
Research Site
Shatin,
Hong KongActive - Recruiting
Research Site
Alessandria, 15121
ItalyActive - Recruiting
Research Site
Bologna, 40138
ItalyActive - Recruiting
Research Site
Busto Arsizio, 21052
ItalyActive - Recruiting
Research Site
Milan, 20141
ItalyActive - Recruiting
Research Site
Milan 6951411, 20132
ItalyActive - Recruiting
Research Site
Roma, 161
ItalySite Not Available
Research Site
Chiba, 260-8717
JapanActive - Recruiting
Research Site
Kashiwa, 277-8577
JapanActive - Recruiting
Research Site
Kumamoto, 860-0008
JapanActive - Recruiting
Research Site
Kōtoku, 135-8550
JapanActive - Recruiting
Research Site
Niigata, 951-8520
JapanActive - Recruiting
Research Site
Okayama, 700-8558
JapanActive - Recruiting
Research Site
Osaka, 541-8567
JapanActive - Recruiting
Research Site
Yokohama, 241-8515
JapanActive - Recruiting
Research Site
Seoul, 03080
Korea, Republic ofActive - Recruiting
Research Site
Seoul, 03080
South KoreaActive - Recruiting
Research Site
Seoul 1835848, 03080
South KoreaActive - Recruiting
Research Site
Barcelona, 08035
SpainActive - Recruiting
Research Site
Madrid, 28040
SpainActive - Recruiting
Research Site
Pozuelo de Alarcón, 28223
SpainActive - Recruiting
Research Site
Gothenburg, 41345
SwedenActive - Recruiting
Research Site
Stockholm, 17176
SwedenActive - Recruiting
Research Site
Kaohsiung City, 80756
TaiwanSite Not Available
Research Site
Kaohsiung City 1673820, 80756
TaiwanSite Not Available
Research Site
Taichung, 40705
TaiwanActive - Recruiting
Research Site
Taichung 1668399, 404
TaiwanActive - Recruiting
Research Site
Tainan, 70403
TaiwanActive - Recruiting
Research Site
Taipei, 106
TaiwanActive - Recruiting
Research Site
London, SE5 9RS
United KingdomActive - Recruiting
Research Site
Manchester, M20 4BX
United KingdomActive - Recruiting
Research Site
Norwich, NR4 7UY
United KingdomActive - Recruiting
Research Site
Nottingham, NG5 1PB
United KingdomActive - Recruiting
Research Site
Plymouth, PL6 8DH
United KingdomActive - Recruiting
Research Site
Phoenix, Arizona 85054
United StatesSite Not Available
Research Site
Duarte, California 91010
United StatesActive - Recruiting
Research Site
Jacksonville, Florida 32224
United StatesSite Not Available
Research Site
Tampa, Florida 33612
United StatesActive - Recruiting
Research Site
Chicago, Illinois 60637
United StatesActive - Recruiting
Research Site
Iowa City, Iowa 52242
United StatesSite Not Available
Research Site
Waukee, Iowa 50263
United StatesActive - Recruiting
Research Site
Overland Park, Kansas 66204
United StatesSite Not Available
Research Site
Rochester, Minnesota 55905
United StatesActive - Recruiting
Research Site
St 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 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 StatesActive - Recruiting
Research Site
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Research Site
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Research Site
Pittsburgh 5206379, Pennsylvania 6254927 15232
United StatesActive - Recruiting
Research Site
Nashville, Tennessee 37203
United StatesActive - Recruiting
Research Site
Austin, Texas 78704
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
San Antonio, Texas 78229
United StatesSite Not Available
Research Site
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting

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