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

  • Interventional
  • Recruiting
  • NCT04245722
Eligibility Details Visit Clinicaltrials.gov

A Phase I, Open-Label, Multicenter Study of FT596 as a Monotherapy and in Combination With Rituximab or Obinutuzumab in Subjects With Relapsed/Refractory B-cell Lymphoma and Chronic Lymphocytic Leukemia

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.


Age Group
18 Years and up

Accepting Healthy Volunteers?

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 two prior systemic treatment regimens


         - 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:


         - 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

At a Glance

National Government IDNCT04245722


Lead SponsorFate Therapeutics

Lead PhysicianPeter Riedell


18 Years and up