FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

This is a Phase I study of FT596 in combination with two different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will consist of a dose-escalation stage followed by a dose-expansion stage.

This is a Phase I study of FT596 in combination with 2 different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment.

The study will evaluate both the clinical benefit of FT596 when combined with R-CHOP given on a standard or alternate schedule.

Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. After safety and tolerability have been assessed to define the maximum tolerated dose (MTD) (or the maximum assessed dose [MAD] in the absence of dose limiting toxicities [DLTs] defining the MTD) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of FT596 in combination.

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)