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

October 25, 2023 updated by: Fate Therapeutics

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

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
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Masonic Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10016
        • NYU Langone Health
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute (Tennessee Oncology)
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • SCRI-TTI
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

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
  • 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

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 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
  • 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

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: FT596 Monotherapy, Lymphoma
FT596 monotherapy in adult subjects with r/r B-cell Lymphoma
Drug: Bendamustine
Conditioning agent
Other Names:
  • Treanda
  • Bendeka
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Drug: FT596
Experimental Interventional Therapy
Experimental: FT596 in Combination with Rituximab, Lymphoma
FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
Drug: Rituximab
Monoclonal Antibody
Other Names:
  • Rituxan
  • Ruxience
  • Truxima
Drug: Bendamustine
Conditioning agent
Other Names:
  • Treanda
  • Bendeka
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Drug: FT596
Experimental Interventional Therapy
Experimental: FT596 in Combination with Obinutuzumab, Lymphoma
FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
Drug: Obinutuzumab
Monoclonal Antibody
Other Names:
  • Gazyva
Drug: Bendamustine
Conditioning agent
Other Names:
  • Treanda
  • Bendeka
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Drug: FT596
Experimental Interventional Therapy
Experimental: FT596 Monotherapy, CLL
FT596 monotherapy in adult subjects with r/r CLL
Drug: Bendamustine
Conditioning agent
Other Names:
  • Treanda
  • Bendeka
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Drug: FT596
Experimental Interventional Therapy
Experimental: FT596 in Combination with Obinutuzumab, CLL
FT596 in combination with Obinutuzumab in adult subjects with r/r CLL
Drug: Obinutuzumab
Monoclonal Antibody
Other Names:
  • Gazyva
Drug: Bendamustine
Conditioning agent
Other Names:
  • Treanda
  • Bendeka
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Drug: FT596
Experimental Interventional Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose-limiting toxicities within each dose level cohort
Time Frame: Day 29
Day 29
Nature of dose-limiting toxicities within each dose level cohort
Time Frame: Day 29
Day 29
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
Time Frame: Up to 15 years
Up to 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator-assessed objective-response rate (ORR)
Time Frame: From baseline tumor assessment up to approximately 2 years after last dose of FT596
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.
From baseline tumor assessment up to approximately 2 years after last dose of FT596
Investigator-assessed duration of objective response (DOR)
Time Frame: Up to 15 years
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.
Up to 15 years
Investigator-assessed duration of complete response (DoCR)
Time Frame: Up to 15 years
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.
Up to 15 years
Progression-free survival (PFS)
Time Frame: Up to 15 years
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
Up to 15 years
Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause.
Time Frame: Up to 15 years
Up to 15 years
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
Time Frame: Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29
Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29

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.

General Publications

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)

March 19, 2020

Primary Completion (Actual)

September 27, 2023

Study Completion (Actual)

September 27, 2023

Study Registration Dates

First Submitted

January 18, 2020

First Submitted That Met QC Criteria

January 26, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT596-101

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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