for people ages 18 years and up (full criteria)
at UC Davis UCLA
study started
completion around



This is a Phase I dose-finding study of FT819 as monotherapy and in combination with IL-2 in subjects with relapsed/refractory B-cell Lymphoma, Chronic Lymphocytic Leukemia and Precursor B-cell Acute Lymphoblastic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

Official Title

A Phase I Study of FT819 in Subjects With B-cell Malignancies


Lymphoma, B-Cell, Chronic Lymphocytic Leukemia, Precursor B-Cell Acute Lymphoblastic Leukemia, Lymphoma, Leukemia, BCL, CLL, B-ALL, CAR-T, cellular therapy, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, B-Cell Lymphoma, Cyclophosphamide, Bendamustine Hydrochloride, Fludarabine, Interleukin-2, Bendamustine, FT819 Step Fractionated Monotherapy, B-Cell Lymphoma, FT819 Step Fractionated Monotherapy, CLL, FT819 Step Fractionated Monotherapy, B-ALL


You can join if…

Open to people ages 18 years and up

Diagnosis of B-cell lymphoma, CLL or B-ALL as described below:

B-Cell Lymphoma:

  • Histologically documented lymphomas expected to express CD19
  • Relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy

Chronic Lymphocytic Leukemia (CLL):

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

Precursor B-cell Acute Lymphocytic Leukemia (B-ALL):

  • Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics
  • Relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen


  • 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

You CAN'T join if...


  • Females who are pregnant or breastfeeding
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
  • Body weight <50 kg
  • Evidence of insufficient organ function
  • Receipt of 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
  • Ongoing requirement for systemic GvHD therapy following prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T
  • 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
  • Positive serologic test results for HIV infection
  • Positive serologic and polymerase chain reaction (PCR) test results for Hepatitis B (HBV) infection
  • Positive serologic and PCR test results for Hepatitis C (HCV) infection
  • Live vaccine <6 weeks prior to start of lympho-conditioning
  • Known allergy to albumin (human) or DMSO


  • UC Davis accepting new patients
    Davis California 95817 United States
  • UCLA Ronald Reagan Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Stanford Cancer Institute accepting new patients
    Palo Alto California 94304 United States


accepting new patients
Start Date
Completion Date
Fate Therapeutics
ASH 2022 Poster Presentation ASH 2022 Abstract
Phase 1 research study
Study Type
Expecting 396 study participants
Last Updated