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Lymphoma, B-CellPhase 1NCT04629729

FT819 in Subjects With B-cell Malignancies

A Phase 1 study testing FT819, Cyclophosphamide and Fludarabine in people with Lymphoma, B-Cell and Chronic Lymphocytic Leukemia, run by Fate Therapeutics at 18 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FT819, Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
18 sitesUnited States
Study dates
12 Jul 2021to 30 Sep 2039
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • UC Davis

    Davis, California, 95817

  • University of Florida

    Gainesville, Florida, 32608

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • Mayo Florida

    Jacksonville, Florida, 32224

  • Scripps Green Hospital

    La Jolla, California, 92037

  • UCLA Ronald Reagan Medical Center

    Los Angeles, California, 90095

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky, 40207

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53705

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Stanford Cancer Institute

    Palo Alto, California, 94304

  • Mayo Arizona

    Phoenix, Arizona, 85054

  • Oregon Health & Sciences University

    Portland, Oregon, 97239

  • Mayo Minnesota

    Rochester, Minnesota, 55905

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: 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.

Being tested
FT819, Cyclophosphamide, Fludarabine, IL-2, Bendamustine
Keywords
Lymphoma, Leukemia, BCL, CLL, B-ALL, CAR-T, cellular therapy
Medical subject headings
Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FT819Drug

    Experimental Interventional Therapy

  • CyclophosphamideDrug

    Lympho-conditioning agent

  • FludarabineDrug

    Also called Fludara

    Lympho-conditioning agent

  • IL-2Drug

    Also called Interleukin-2

    Biologic response modifier

  • BendamustineDrug

    Also called Bendeka, Treanda

    Lympho-conditioning agent

Study groups in NCT04629729
Study groupRoleWhat they receive
FT819 Single-Dose Monotherapy, B-Cell LymphomaExperimentalFT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
FT819 Single-Dose in Combination with IL-2, B-Cell LymphomaExperimentalFT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2; Drug: Bendamustine
FT819 Step Fractionated Monotherapy, B-Cell LymphomaExperimentalFT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
FT819 Single-Dose Monotherapy, CLLExperimentalFT819 single-dose monotherapy in adult subjects with r/r CLL
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
FT819 Single-Dose in Combination with IL-2, CLLExperimentalFT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2; Drug: Bendamustine
FT819 Step Fractionated Monotherapy, CLLExperimentalFT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
FT819 Single-Dose Monotherapy, B-ALLExperimentalFT819 single-dose monotherapy in adult subjects with r/r B-ALL
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
FT819 Single-Dose in Combination with IL-2, B-ALLExperimentalFT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2; Drug: Bendamustine
FT819 Step Fractionated Monotherapy, B-ALLExperimentalFT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell LymphomaExperimentalFT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2; Drug: Bendamustine
FT819 Step Fractionated Monotherapy in Combination with IL-2, CLLExperimentalFT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2; Drug: Bendamustine
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALLExperimentalFT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
Receives: Drug: FT819; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2; Drug: Bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and nature of dose-limiting toxicities within each dose level cohort

    Measured: Up to Day 29

  2. 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

    Measured: Up to 15 years

Secondary outcomes (7)

  1. Investigator-assessed objective-response rate (ORR)

    Measured: Up to approximately 2 years after last dose of FT819

  2. For BCL and CLL Only: Investigator-assessed duration of objective response (DOR)

    Measured: Up to 15 years

  3. For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)

    Measured: Up to 15 years

  4. For BCL and CLL Only: Progression-free survival (PFS)

    Measured: Up to 15 years

  5. Overall survival (OS)

    Measured: Up to 15 years

  6. Determination of the pharmacokinetics of FT819 cells in peripheral blood.

    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

    Measured: Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29

  7. For B-ALL Only: Investigator-assessed relapse-free survival (RFS)

    Measured: Up to 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2020
  2. Study start12 Jul 2021
  3. Primary completion18 Jun 2025
  4. Study completion30 Sep 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04629729
Sponsor's protocol ID
FT819-101
Status last verified
Mar 2026
First submitted
10 Nov 2020
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FT819, Cyclophosphamide and Fludarabine in people with Lymphoma, B-Cell and Chronic Lymphocytic Leukemia, run by Fate Therapeutics at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and nature of dose-limiting toxicities within each dose level cohort (time frame: Up to Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04629729.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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