AzTrials
AzTrials

Acute Myelogenous LeukemiaPhase 1NCT04023071

FT516 in Subjects With Advanced Hematologic Malignancies

A Phase 1 study testing FT516, Rituximab and Obinutuzumab in people with Acute Myelogenous Leukemia and B-cell Lymphoma, run by Fate Therapeutics at 7 sites in United States.

Terminated

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

Official record
Search all trials

Trial summary

This is a Phase 1/1b dose-finding study of FT516 as monotherapy in acute myeloid leukemia (AML) and in combination with CD20 directed monoclonal antibodies in B-cell lymphoma. The study includes three stages: dose escalation, safety confirmation, and dose expansion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myelogenous Leukemia, B-cell Lymphoma
What is being tested?
FT516, Rituximab and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
7 sitesUnited States
Study dates
4 Oct 2019to 23 Oct 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 the following:
  • Regimen A (FT516 monotherapy):
  • Primary Refractory AML
  • Relapsed AML defined as not in CR after 1 or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required
  • Regimen B (FT516 + rituximab or obinutuzumab):
  • Histologically documented B-cell lymphoma expected to express CD20 who have relapsed after or failed to respond to at least on prior treatment regimen and for whom there is no available therapy expected to improve survival.
Show all 11Show fewer
  • All subjects:
  • Provision of signed and dated informed consent form (ICF)
  • Age ≥18 years old
  • Stated willingness to comply with study procedures and duration
  • Presence of measurable disease

Who cannot join

  • All subjects:
  • Females of reproductive potential who are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
  • Evidence of insufficient organ function
  • Receipt of therapy within 2 weeks prior to Cycle 1 Day 1 or within five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Cycle 1 Day 1
  • Currently receiving or likely to require systemic immunosuppressive therapy
Show all 15Show fewer
  • Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Cycle 1 Day 1, or ongoing requirement for systemic graft-versus-host therapy
  • Receipt of an allograft organ transplant
  • Known active central nervous system (CNS) involvement by malignancy.
  • Clinically significant cardiovascular disease
  • Clinically significant infections including: 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 human albumin and DMSO
  • Additional Exclusion Criteria for FT516 monotherapy Regimen: Diagnosis of promyelocytic leukemia with t(15:17) translocation
  • Additional Exclusion Criteria for FT516 plus monoclonal antibody Regimens: Diagnosis of Waldenstrom macroglobulinemia

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • UT Southwestern

    Dallas, Texas, 75390

  • University of Colorado, Denver

    Denver, Colorado, 80045

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Minnesota Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • UC San Diego

    San Diego, California, 92037

  • Swedish Cancer Institute

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: A Phase I Study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory B-Cell Lymphoma

This is a Phase 1/1b dose-finding study of FT516 as monotherapy in acute myeloid leukemia (AML) and in combination with CD20 directed monoclonal antibodies in B-cell lymphoma. The study includes three stages: dose escalation, safety confirmation, and dose expansion.

Keywords
AML, Lymphoma
Medical subject headings
Leukemia, Myeloid, Acute, Lymphoma, B-Cell, Lymphoma

What participants receive

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

  • FT516Drug

    Experimental Interventional Therapy

  • RituximabDrug

    Also called Rituxan, MabThera

    Monoclonal Antibody

  • ObinutuzumabDrug

    Also called Gazyva

    Monoclonal Antibody

  • CyclophosphamideDrug

    Conditioning agent

  • FludarabineDrug

    Conditioning agent

  • IL-2Drug

    Biologic response modifier

  • BendamustineDrug

    Also called Bendeka, Treanda

    Conditioning agent

Study groups in NCT04023071
Study groupRoleWhat they receive
FT516 MonotherapyExperimentalFT516 monotherapy in adult subjects with r/r AML.
Receives: Drug: FT516; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2
FT516 in Combination with Monoclonal AntibodiesExperimentalFT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
Receives: Drug: FT516; Drug: Rituximab; Drug: Obinutuzumab; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing ScheduleExperimentalFT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
Receives: Drug: FT516; Drug: Rituximab; Drug: Obinutuzumab; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2
FT516 in Combination with Monoclonal Antibodies following Bendamustine ConditioningExperimentalBendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
Receives: Drug: FT516; Drug: Rituximab; Drug: Obinutuzumab; Drug: IL-2; Drug: Bendamustine

What is being measured

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

  1. The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.

    Measured: Day 29

  2. Incidence, nature, and severity of AEs, of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.

    Measured: Up to 5 years

Secondary outcomes (2)

  1. Investigator-assessed anti-tumor activity of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.

    Measured: Cycle 2 Day 29

  2. FT516 pharmacokinetic data

    Percentage of donor DNA measured at each timepoint

    Measured: Cycle 1 and Cycle 2 Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29, and Cycle 2 Day 43 and Cycle 2 Day 57.

Timeline

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

  1. First posted17 Jul 2019
  2. Study start4 Oct 2019
  3. Primary completion23 Oct 2023
  4. Study completion23 Oct 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
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04023071
Sponsor's protocol ID
FT516-101
Status last verified
Oct 2023
First submitted
9 Jul 2019
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Strati P, Castro J, Goodman A, Bachanova V, Kamdar M, Awan FT, Solomon SR, Wong L, Wong C, Patel D, Bickers C, Zhao W, Bashir Z, Valamehr B, Elstrom RL, Patel K. Off-the-shelf induced pluripotent stem-cell-derived natural killer-cell therapy in relapsed or refractory B-cell lymphoma: a multicentre, open-label, phase 1 study. Lancet Haematol. 2025 Jul;12(7):e505-e515. doi: 10.1016/S2352-3026(25)00142-5.

    PubMed 40610174

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FT516, Rituximab and Obinutuzumab in people with Acute Myelogenous Leukemia and B-cell Lymphoma, run by Fate Therapeutics at 7 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 11 inclusion and 15 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 7 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?

The incidence of subjects with Dose Limiting Toxicities within each dose level cohort. (time frame: 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 NCT04023071, which also lists 1 linked publication.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in