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Lymphoma, B-CellPhase 1NCT04245722

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

A Phase 1 study testing FT596, Cyclophosphamide and Fludarabine in people with Lymphoma, B-Cell and Chronic Lymphocytic Leukemia, run by Fate Therapeutics at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FT596, Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
9 sitesUnited States
Study dates
19 Mar 2020to 27 Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 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
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  • Relapsed/refractory disease following at least two prior systemic treatment regimens
  • 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 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
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • The University of Chicago

    Chicago, Illinois, 60637

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Minnesota Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Sarah Cannon Research Institute (Tennessee Oncology)

    Nashville, Tennessee, 37203

  • NYU Langone Health

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • SCRI-TTI

    San Antonio, Texas, 78229

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: 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.

Keywords
Lymphoma, Leukemia
Medical subject headings
Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Leukemia

What participants receive

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

  • FT596Drug

    Experimental Interventional Therapy

  • CyclophosphamideDrug

    Lympho-conditioning agent

  • FludarabineDrug

    Lympho-conditioning agent

  • RituximabDrug

    Also called Rituxan, Truxima, Ruxience

    Monoclonal Antibody

  • ObinutuzumabDrug

    Also called Gazyva

    Monoclonal Antibody

  • BendamustineDrug

    Also called Bendeka, Treanda

    Conditioning agent

Study groups in NCT04245722
Study groupRoleWhat they receive
FT596 Monotherapy, LymphomaExperimentalFT596 monotherapy in adult subjects with r/r B-cell Lymphoma
Receives: Drug: FT596; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
FT596 in Combination with Rituximab, LymphomaExperimentalFT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
Receives: Drug: FT596; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Rituximab; Drug: Bendamustine
FT596 in Combination with Obinutuzumab, LymphomaExperimentalFT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
Receives: Drug: FT596; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Obinutuzumab; Drug: Bendamustine
FT596 Monotherapy, CLLExperimentalFT596 monotherapy in adult subjects with r/r CLL
Receives: Drug: FT596; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
FT596 in Combination with Obinutuzumab, CLLExperimentalFT596 in combination with Obinutuzumab in adult subjects with r/r CLL
Receives: Drug: FT596; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Obinutuzumab; Drug: Bendamustine

What is being measured

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

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

    Measured: Day 29

  2. Nature of dose-limiting toxicities within each dose level cohort

    Measured: Day 29

  3. Incidence, nature, and severity of adverse events (AEs) of FT596 as monotherapy and in combination with rituximab or obinutuzumab in r/r B-cell lymphomas and r/r chronic lymphocytic leukemia, with severity determined according to NCI CTCAE, v5.0

    Measured: Up to 15 years

Secondary outcomes (6)

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

    Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification for lymphomas, a partial remission (PR) or complete remission (CR) per revised iwCLL guidelines for CLL.

    Measured: From baseline tumor assessment up to approximately 2 years after last dose of FT596

  2. Investigator-assessed duration of objective response (DOR)

    Defined as the duration from the first occurrence of a documented objective response (DOR) until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL.

    Measured: Up to 15 years

  3. Investigator-assessed duration of complete response (DoCR)

    Defined as the duration from the first occurrence of a documented complete response (CR) per Lugano 2014 classification for lymphomas or complete remission (CR) per revised iwCLL guidelines for CLL, until the time of disease progression or relapse, or death from any cause, whichever occurs first.

    Measured: Up to 15 years

  4. Progression-free survival (PFS)

    Defined as the time from from first dose of lympho-conditioning to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL

    Measured: Up to 15 years

  5. Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause.

    Measured: Up to 15 years

  6. The pharmacokinetics of FT596 in peripheral blood will be reported as the relative percentage of product (FT596) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points

    Measured: Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29

Timeline

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

  1. First posted29 Jan 2020
  2. Study start19 Mar 2020
  3. Primary completion27 Sep 2023
  4. Study completion27 Sep 2023

Why it stopped: The study was terminated by the Sponsor.

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
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04245722
Sponsor's protocol ID
FT596-101
Status last verified
Oct 2023
First submitted
18 Jan 2020
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li Y, Hermanson DL, Moriarity BS, Kaufman DS. Human iPSC-Derived Natural Killer Cells Engineered with Chimeric Antigen Receptors Enhance Anti-tumor Activity. Cell Stem Cell. 2018 Aug 2;23(2):181-192.e5. doi: 10.1016/j.stem.2018.06.002. Epub 2018 Jun 28.

    PubMed 30082067

  • Ghobadi A, Bachanova V, Patel K, Park JH, Flinn I, Riedell PA, Bachier C, Diefenbach CS, Wong C, Bickers C, Wong L, Patel D, Goodridge J, Denholt M, Valamehr B, Elstrom RL, Strati P. Induced pluripotent stem-cell-derived CD19-directed chimeric antigen receptor natural killer cells in B-cell lymphoma: a phase 1, first-in-human trial. Lancet. 2025 Jan 11;405(10473):127-136. doi: 10.1016/S0140-6736(24)02462-0.

    PubMed 39798981

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FT596, Cyclophosphamide and Fludarabine in people with Lymphoma, B-Cell and Chronic Lymphocytic Leukemia, run by Fate Therapeutics at 9 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 12 inclusion and 16 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: stopped early, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

The study was stopped early (reason given: The study was terminated by the Sponsor.). Results are not available in the source record.

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 of dose-limiting toxicities within each dose level cohort (time frame: Day 29). The study lists 3 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 NCT04245722, which also lists 2 linked publications.

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 26 Oct 2023.

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