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Trial record 1 of 1 for:    NCT04245722
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FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies

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ClinicalTrials.gov Identifier: NCT04245722
Recruitment Status : Active, not recruiting
First Posted : January 29, 2020
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

Study Description
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Brief 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. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Chronic Lymphocytic Leukemia Drug: FT596 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rituximab Drug: Obinutuzumab Drug: Bendamustine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 19, 2020
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2039

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: FT596 Monotherapy, Lymphoma
FT596 monotherapy in adult subjects with r/r B-cell Lymphoma
 Drug: FT596
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Drug: Bendamustine
Conditioning agent
Other Names:
  • Bendeka
  • Treanda
Experimental: FT596 in Combination with Rituximab, Lymphoma
FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
 Drug: FT596
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Drug: Rituximab
Monoclonal Antibody
Other Names:
  • Rituxan
  • Truxima
  • Ruxience

Drug: Bendamustine
Conditioning agent
Other Names:
  • Bendeka
  • Treanda
Experimental: FT596 in Combination with Obinutuzumab, Lymphoma
FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
 Drug: FT596
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Drug: Obinutuzumab
Monoclonal Antibody
Other Name: Gazyva

Drug: Bendamustine
Conditioning agent
Other Names:
  • Bendeka
  • Treanda
Experimental: FT596 Monotherapy, CLL
FT596 monotherapy in adult subjects with r/r CLL
 Drug: FT596
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Drug: Bendamustine
Conditioning agent
Other Names:
  • Bendeka
  • Treanda
Experimental: FT596 in Combination with Obinutuzumab, CLL
FT596 in combination with Obinutuzumab in adult subjects with r/r CLL
 Drug: FT596
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Drug: Obinutuzumab
Monoclonal Antibody
Other Name: Gazyva

Drug: Bendamustine
Conditioning agent
Other Names:
  • Bendeka
  • Treanda


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities within each dose level cohort [ Time Frame: Day 29 ]
  2. Nature of dose-limiting toxicities within each dose level cohort [ Time Frame: 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 [ Time Frame: Up to 15 years ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause. [ Time Frame: 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 [ Time Frame: Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245722


Locations
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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Minnesota
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
NYU Langone Health
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Tennessee
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
SCRI-TTI
San Antonio, Texas, United States, 78229
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Fate Therapeutics
Investigators
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Study Director: Fate Trial Disclosure Fate Therapeutics
More Information
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Publications:

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Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT04245722    
Other Study ID Numbers: FT596-101
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fate Therapeutics:
Lymphoma
Leukemia
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes
 Lymphoma, Non-Hodgkin
Cyclophosphamide
Bendamustine Hydrochloride
Rituximab
Fludarabine
Obinutuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists