FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies

Key Inclusion Criteria:

Diagnosis of B-cell lymphoma or leukemia-cll/" >CLL as described below:

B-Cell Lymphoma:

Histologically documented lymphomas expected to express CD19 and CD20
Relapsed/refractory disease following prior systemic immunochemotherapy regimen

Chronic Lymphocytic Leukemia (CLL):

Diagnosis of CLL per iwCLL guidelines
Relapsed/refractory disease following at least two prior systemic treatment regimens

ALL SUBJECTS:

Capable of giving signed informed consent
Age ≥ 18 years old
Stated willingness to comply with study procedures and duration
Contraceptive use for women and men as defined in the protocol

Key Exclusion Criteria:

ALL SUBJECTS:

Females who are pregnant or breastfeeding
Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
Body weight <50 kg
Evidence of insufficient organ function
Receipt therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1
Currently receiving or likely to require systemic immunosuppressive therapy
Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy
Receipt of an 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
Known HIV infection
Known active Hepatitis B (HBV) or Hepatitis C (HCV) infection
Live vaccine <6 weeks prior to start of lympho-conditioning
Known allergy to albumin (human) or DMSO