FT819 in Subjects With B-cell Malignancies


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Trial ID: NCT04629729


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

Stanford Investigator(s)

David Miklos
David Miklos

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


Key Inclusion Criteria:

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

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

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 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


drug: FT819

drug: Cyclophosphamide

drug: Fludarabine

drug: IL-2

drug: Bendamustine


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Iglesias
+1 650-723-4247

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