Phase
Condition
Lymphoma
Non-hodgkin's Lymphoma
Lymphoma, B-cell
Treatment
ARV-393
Glofitamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For Part A and B: Have relapsed/refractory NHL and >=2 prior systemic therapies, (including rituximab), and be ineligible for known therapies with demonstratedclinical benefit per investigator assessment or, histologically confirmed AITL thathas recurred or progressed following institutional standard of care therapy.
For Part C and D: Have R/R DLBCL, not otherwise specified [NOS (DLBCL, NOS)] orlarge B-cell lymphoma (LBCL) arising from follicular lymphoma and have received twoor more lines of systemic therapy.
Have at least one bi dimensionally measurable lesion >1.5-centimeter (cm) in largestdimension for nodal or >1.0 cm for extranodal lesion.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (NOTE:For Part A only - ECOG PS of 2 is allowed for participants with secondary CNSlymphoma).
Adequate bone marrow function
Adequate kidney function
Adequate Liver Function
Exclusion
Exclusion Criteria:
Current or past history of peripheral eosinophilia, hypereosinophilic syndrome (HES), organ-specific eosinophilic disorder, or drug reaction with eosinophilia andsystemic symptoms (DRESS), except for peripheral eosinophilia due to disease understudy. Participants with current or prior eosinophilia requiring systemic steroidtreatment are excluded regardless of etiology.
Prior allogeneic stem cell transplant (SCT) or solid organ transplantation.
Prior treatment with chimeric antigen receptor (CAR) T-cell therapy within 60 daysprior to Cycle 1 Day 1 (C1D1) or any prior treatment with a BCL6-targeted therapy
Any other active malignancy within 3 years prior to enrollment, except foradequately treated basal cell or squamous cell skin cancer, melanoma in situ orcarcinoma in situ of the breast or cervix, and prostate cancer with activesurveillance.
Any of the following in the previous 6 months:
Myocardial infarction, long QT syndrome or family history of long QT syndrome,or Torsade de Pointes;
Clinically important atrial or ventricular arrhythmias;
Serious conduction system abnormalities, 3rd degree atrioventricular (AVblock), unstable angina, coronary/peripheral artery bypass graft, symptomaticcongestive heart failure (CHF), New York Heart Association Class III or IV;
Cerebrovascular accident, transient ischemic attack, symptomatic pulmonaryembolism, and/or other clinically significant episode of thromboembolicdisease;
Active inflammatory gastrointestinal (GI) disease, chronic diarrhea, previousgastric resection, or lap band surgery.
Uncontrolled hypertension despite optimal medical treatment
History of myocarditis.
In ability to comply with listed prohibited treatments.
Standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevantabnormalities that may affect participant safety or interpretation of study results.
Cardiac ejection fraction <45%.
Study Design
Study Description
Connect with a study center
Clinical Trial SIte
East Melbourne, Victoria 3002
AustraliaActive - Recruiting
Clinical Trial SIte
Calgary, Alberta T2N 5G2
CanadaActive - Recruiting
Clinical Trial Site
Toronto, Ontario M5G 1Z5
CanadaActive - Recruiting
Clinical Trial Site
Montreal, Quebec H3T 1E2
CanadaActive - Recruiting
Clinical Trial Site
Copenhagen, 2100
DenmarkActive - Recruiting
Clinical Trial Site
Odense C, 5000
DenmarkActive - Recruiting
Clinical Trial Site
El Palmar, Murcia 30120
SpainActive - Recruiting
Clinical Trial Site
Pamplona, Navarre 31008
SpainActive - Recruiting
Clinical Trial Site
Barcelona, 8908
SpainActive - Recruiting
Clinical Trial Site
Madrid, 28050
SpainActive - Recruiting
Clinical Trial Site
Salamanca, 37007
SpainActive - Recruiting
Clinical Trial Site
New Haven, Connecticut 06510
United StatesActive - Recruiting
Clinical Trial Site
Miami, Florida 33136
United StatesActive - Recruiting
Clinical Trial Site
Detroit, Michigan 48201
United StatesActive - Recruiting
Clinical Trial Site
New Brunswick, New Jersey 10065
United StatesActive - Recruiting
Clinical Trial Site
New York, New York 10021
United StatesActive - Recruiting
Clinical Trial Site
New York 5128581, New York 5128638 10016
United StatesActive - Recruiting
Clinical Trial Site
Cleveland, Ohio 44122
United StatesActive - Recruiting
Clinical Trial Site
Nashville, Tennessee 37203
United StatesSite Not Available
Clinical Trial Site
Houston, Texas 77030
United StatesActive - Recruiting
Clinical Trial Site
Charlottesville, Virginia 22908
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.