FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
Diffuse Large B Cell Lymphoma, Transformed Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma
About this trial
This is an interventional treatment trial for Diffuse Large B Cell Lymphoma
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of B-cell lymphoma (BCL) as described below: Histologically documented BCL Previously untreated or no more than one prior systemic therapy for BCL At least one bi-dimensionally measurable lesion Subjects with >1 measurable lesion agreement to undergo a biopsy Capable of giving signed informed consent Age ≥ 18 years old Stated willingness to comply with study procedures through study duration Contraception use for women and men as defined in the protocol Negative serum pregnancy test within 7 days of treatment for women Key Exclusion Criteria: Prior anthracycline therapy Females who are pregnant or breastfeeding Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2 Evidence of insufficient organ function Currently receiving or likely to receive systemic immunosuppressive therapy Receipt of allograft organ transplant Known active central nervous system (CNS) involvement by malignancy Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease Clinically significant cardiovascular disease Positive HIV test Positive Hepatitis B (HBV) or Hepatitis C (HCV) test Live vaccine <6 weeks prior to start of conditioning Allergy to human albumin or dimethyl sulfoxide (DMSO)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Regimen A (FT596 in combination with standard schedule R-CHOP)
Regimen B (FT596 in combination with alternate schedule R-CHOP)
FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.
FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles