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

Sponsor
Fate Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04245722
Collaborator
(none)
552
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5
229.4
61.3
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Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
552 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 :
Mar 19, 2020
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2039

Arms and Interventions

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

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
  • 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 Names:
  • Gazyva
  • 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

    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 Names:
  • Gazyva
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of dose-limiting toxicities within each dose level cohort [Day 29]

    2. Nature of dose-limiting toxicities within each dose level cohort [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 [Up to 15 years]

    Secondary Outcome Measures

    1. Investigator-assessed objective-response rate (ORR) [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) [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) [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) [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. [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 [Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 The University of Chicago Chicago Illinois United States 60637
    2 University of Minnesota Masonic Cancer Center Minneapolis Minnesota United States 55455
    3 Washington University School of Medicine Saint Louis Missouri United States 63110
    4 NYU Langone Health New York New York United States 10016
    5 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    6 Sarah Cannon Research Institute (Tennessee Oncology) Nashville Tennessee United States 37203
    7 MD Anderson Cancer Center Houston Texas United States 77030
    8 SCRI-TTI San Antonio Texas United States 78229
    9 Swedish Cancer Institute Seattle Washington United States 98104

    Sponsors and Collaborators

    • Fate Therapeutics

    Investigators

    • Study Director: Rebecca Elstrom, MD, Fate Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fate Therapeutics
    ClinicalTrials.gov Identifier:
    NCT04245722
    Other Study ID Numbers:
    • FT596-101
    First Posted:
    Jan 29, 2020
    Last Update Posted:
    Jun 27, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fate Therapeutics
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 27, 2022