Phase
Condition
Follicular Lymphoma
Treatment
MK-1045
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic linesof therapy.
Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuselarge B-cell lymphoma (DLBCL).
DLBCL participants only: has progressed after or is ineligible for transplant andchimeric antigen receptor T (cell) (CAR-T) therapy.
Has provided tumor tissue sample (archival or newly obtained, if performed perstandard of care).
Has documented retained expression of cluster of differentiation 19 (CD19) in tumortissue obtained by biopsy after disease progression on CD19-targeting therapy, ifexperienced disease progression after prior CD19-targeting therapy.
Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy ifhas a history of HIV infection.
Has undetectable hepatitis B virus (HBV) viral load and received and will continueto receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviraltherapy if has a history of HCV infection.
Has radiographically measurable disease per Lugano Response Criteria.
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has received a solid organ transplant.
Had or has clinically relevant central nervous system (CNS) diseases.
Has a history of serious cardiovascular or cerebrovascular diseases.
Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement,diarrhea, or increased serum bilirubin; or requires systemic immunosuppression forGVHD.
Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman'sDisease.
Has received a live or live-attenuated vaccine within 30 days of randomization.
Has received prior CAR-T therapy within 3 months before the first dose of the studyintervention.
Has a known additional malignancy that is progressing or required active treatmentwithin the past 2 years.
Has known active CNS lymphoma or involvement.
Has active autoimmune disease that required systemic treatment in the past 2 years.
Has active infection requiring systemic therapy.
Has a history of severe bleeding disorders.
Has not recovered from major surgery or has ongoing surgical complications.
Has diagnosis of primary mediastinal B-cell lymphoma.
Study Design
Connect with a study center
Sanatorio Nuestra Senora del Rosario ( Site 1403)
Rosario, Santa Fe Province 2001
ArgentinaActive - Recruiting
Beijing Cancer hospital ( Site 1701)
Beijing, Beijing Municipality 100142
ChinaActive - Recruiting
Haddasah Medical Center ( Site 0600)
Jerusalem, 9112001
IsraelActive - Recruiting
Shaare Zedek Medical Center ( Site 0603)
Jerusalem, 9103102
IsraelActive - Recruiting
Sheba Medical Center ( Site 0601)
Ramat Gan, 5265601
IsraelActive - Recruiting
Sourasky Medical Center. ( Site 0604)
Tel Aviv, 6423906
IsraelActive - Recruiting
Istituto di Candiolo - IRCCS ( Site 0701)
Candiolo, Piedmont 10060
ItalyActive - Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 0900)
Warsaw, Masovian Voivodeship 02-781
PolandActive - Recruiting
Pratia Onkologia Katowice ( Site 0902)
Katowice, Silesian Voivodeship 40-519
PolandActive - Recruiting
Hospital Universitari Vall de Hebron ( Site 1102)
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario 12 de Octubre ( Site 1105)
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Gregorio Maranon ( Site 1101)
Madrid, 28007
SpainActive - Recruiting
The Christie NHS Foundation Trust ( Site 1300)
Manchester, M20 4BX
United KingdomActive - Recruiting

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