FT819 in Subjects With B-cell Malignancies

March 17, 2026 updated by: Fate Therapeutics

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Arizona
    • California
      • Davis, California, United States, 95817
        • UC Davis
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital
      • Los Angeles, California, United States, 90095
        • UCLA Ronald Reagan Medical Center
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Florida
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Westwood, Kansas, United States, 66205
        • The University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute, St. Matthews Campus
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Minnesota
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University Of Nebraska Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Sciences University
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FT819 Single-Dose Monotherapy, B-Cell Lymphoma
FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka
Experimental: FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
Drug: IL-2
Biologic response modifier
Other Names:
  • Interleukin-2
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka
Experimental: FT819 Step Fractionated Monotherapy, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka
Experimental: FT819 Single-Dose Monotherapy, CLL
FT819 single-dose monotherapy in adult subjects with r/r CLL
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka
Experimental: FT819 Single-Dose in Combination with IL-2, CLL
FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
Drug: IL-2
Biologic response modifier
Other Names:
  • Interleukin-2
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka
Experimental: FT819 Step Fractionated Monotherapy, CLL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka
Experimental: FT819 Single-Dose Monotherapy, B-ALL
FT819 single-dose monotherapy in adult subjects with r/r B-ALL
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka
Experimental: FT819 Single-Dose in Combination with IL-2, B-ALL
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
Drug: IL-2
Biologic response modifier
Other Names:
  • Interleukin-2
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka
Experimental: FT819 Step Fractionated Monotherapy, B-ALL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka
Experimental: FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
Drug: IL-2
Biologic response modifier
Other Names:
  • Interleukin-2
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka
Experimental: FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
Drug: IL-2
Biologic response modifier
Other Names:
  • Interleukin-2
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka
Experimental: FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
Drug: IL-2
Biologic response modifier
Other Names:
  • Interleukin-2
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Fludara
Drug: FT819
Experimental Interventional Therapy
Drug: Bendamustine
Lympho-conditioning agent
Other Names:
  • Treanda
  • Bendeka

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence, nature, and severity of adverse events (AEs) of FT819 as monotherapy and in combination with IL-2 in r/r B-cell lymphoma, r/r chronic lymphocytic leukemia, and r/r precursor B-cell acute lymphoblastic leukemia
Time Frame: Up to 15 years
Up to 15 years
Incidence and nature of dose-limiting toxicities within each dose level cohort
Time Frame: Up to Day 29
Up to Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
For BCL and CLL Only: Investigator-assessed duration of objective response (DOR)
Time Frame: Up to 15 years
Up to 15 years
For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)
Time Frame: Up to 15 years
Up to 15 years
For BCL and CLL Only: Progression-free survival (PFS)
Time Frame: Up to 15 years
Up to 15 years
Overall survival (OS)
Time Frame: Up to 15 years
Up to 15 years
For B-ALL Only: Investigator-assessed relapse-free survival (RFS)
Time Frame: Up to 15 years
Up to 15 years
Determination of the pharmacokinetics of FT819 cells in peripheral blood.
Time Frame: Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29
The PK of FT819 in peripheral blood will be reported as the relative percentage of product (FT819) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29
Investigator-assessed objective-response rate (ORR)
Time Frame: Up to approximately 2 years after last dose of FT819
Up to approximately 2 years after last dose of FT819

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fate Therapeutics

Investigators

  • Study Director: Fate Trial Disclosure, Fate Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Actual)

June 18, 2025

Study Completion (Estimated)

September 30, 2039

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT819-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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