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

Trial Status: Active

This is a Phase I dose-finding study of FT596 as monotherapy and in combination with Rituximab or Obinutuzumab in subjects with relapsed / refractory B-cell Lymphoma or Chronic Lymphocytic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

Inclusion Criteria

  • Key Inclusion Criteria: Diagnosis of B-cell lymphoma or 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 one prior systemic treatment regimen 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 - Prior treatment with CD19 CAR-T therapy unless documented preservation of CD19 antigen is provided - 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

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Fate Therapeutics

  • Primary ID FT596-101
  • Secondary IDs NCI-2020-01589
  • Clinicaltrials.gov ID NCT04245722