A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

Korábbi kezelés

• Prior CAR T-cell or other genetically-modified cell therapy
• Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis

Más betegség

• Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
• Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
• History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies
• History of or active human immunodeficiency virus (HIV)
• Active hepatitis B or active hepatitis C
• Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
• Active autoimmune disease requiring immunosuppressive therapy
• Presence of acute or chronic graft-versus-host=disease
• History of significant cardiovascular disease

Egyéb

• WHO subclassification of duodenal-type FL
• History or presence of clinically relevant central nervous system pathology

• Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology
• Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
• Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one prior line of systemic therapy are eligible if they present with high risk features. Patients that received two or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
• Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) or relapsed after hematopoietic stem cell transplant
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function
• Adequate vascular access for leukapheresis procedure