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FT819 in Subjects With B-cell Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04629729
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

Tracking Information
First Submitted Date  ICMJE November 10, 2020
First Posted Date  ICMJE November 16, 2020
Last Update Posted Date May 3, 2023
Actual Study Start Date  ICMJE July 26, 2021
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2023)
  • Incidence and nature of dose-limiting toxicities within each dose level cohort [ Time Frame: Up to Day 29 ]
  • 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 [ Time Frame: Up to 15 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2020)		 Incidence and nature of dose-limiting toxicities within each dose level cohort [ Time Frame: Day 29 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2023)
  • Investigator-assessed objective-response rate (ORR) [ Time Frame: Up to approximately 2 years after last dose of FT819 ]
  • For BCL and CLL Only: Investigator-assessed duration of objective response (DOR) [ Time Frame: Up to 15 years ]
  • For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR) [ Time Frame: Up to 15 years ]
  • For BCL and CLL Only: Progression-free survival (PFS) [ Time Frame: Up to 15 years ]
  • Overall survival (OS) [ Time Frame: Up to 15 years ]
  • Determination of the pharmacokinetics of FT819 cells in peripheral blood. [ Time Frame: Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29 ]
    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
  • For B-ALL Only: Investigator-assessed relapse-free survival (RFS) [ Time Frame: Up to 15 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2020)
  • 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 [ Time Frame: Up to 15 years ]
  • Investigator-assessed objective-response rate (ORR) [ Time Frame: From baseline assessment up to approximately 2 years after last dose of FT819 ]
  • For BCL and CLL Only: Investigator-assessed duration of objective response (DOR) [ Time Frame: Up to 15 years ]
  • For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR) [ Time Frame: Up to 15 years ]
  • For BCL and CLL Only: Progression-free survival (PFS) [ Time Frame: Up to 15 years ]
  • Overall survival (OS) [ Time Frame: Up to 15 years ]
  • Determination of the pharmacokinetics of FT819 cells in peripheral blood. [ Time Frame: Study Days 1, 2, 3, 4, 5, 6, 8, 11, 15, 18, 22, 25, and 29 ]
    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
  • For B-ALL Only: Investigator-assessed relapse-free survival (RFS) [ Time Frame: Up to 15 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FT819 in Subjects With B-cell Malignancies
Official Title  ICMJE A Phase I Study of FT819 in Subjects With B-cell Malignancies
Brief 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. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, B-Cell
  • Chronic Lymphocytic Leukemia
  • Precursor B-Cell Acute Lymphoblastic Leukemia
Intervention  ICMJE
  • Drug: FT819
    Experimental Interventional Therapy
  • Drug: Cyclophosphamide
    Lympho-conditioning agent
  • Drug: Fludarabine
    Lympho-conditioning agent
    Other Name: Fludara
  • Drug: IL-2
    Biologic response modifier
    Other Name: Interleukin-2
  • Drug: Bendamustine
    Lympho-conditioning agent
    Other Names:
    • Bendeka
    • Treanda
Study Arms  ICMJE
  • Experimental: FT819 Single-Dose Monotherapy, B-Cell Lymphoma
    FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: Bendamustine
  • Experimental: FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
    FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: IL-2
    • Drug: Bendamustine
  • Experimental: FT819 Step Fractionated Monotherapy, B-Cell Lymphoma
    FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: Bendamustine
  • Experimental: FT819 Single-Dose Monotherapy, CLL
    FT819 single-dose monotherapy in adult subjects with r/r CLL
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: Bendamustine
  • Experimental: FT819 Single-Dose in Combination with IL-2, CLL
    FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: IL-2
    • Drug: Bendamustine
  • Experimental: FT819 Step Fractionated Monotherapy, CLL
    FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: Bendamustine
  • Experimental: FT819 Single-Dose Monotherapy, B-ALL
    FT819 single-dose monotherapy in adult subjects with r/r B-ALL
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: Bendamustine
  • Experimental: FT819 Single-Dose in Combination with IL-2, B-ALL
    FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: IL-2
    • Drug: Bendamustine
  • Experimental: FT819 Step Fractionated Monotherapy, B-ALL
    FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: Bendamustine
  • Experimental: FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma
    FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: IL-2
    • Drug: Bendamustine
  • Experimental: FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL
    FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: IL-2
    • Drug: Bendamustine
  • Experimental: FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL
    FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
    Interventions:
    • Drug: FT819
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
    • Drug: IL-2
    • Drug: Bendamustine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2023)		 396
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2020)		 297
Estimated Study Completion Date  ICMJE September 30, 2039
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

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
  • 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

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 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fate Trial Disclosure 866-875-1800 FateTrialDisclosure@fatetherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04629729
Other Study ID Numbers  ICMJE FT819-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Fate Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fate Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fate Trial Disclosure Fate Therapeutics
PRS Account Fate Therapeutics
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP