search
Back to results

FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

Primary Purpose

Diffuse Large B Cell Lymphoma, Transformed Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
FT596
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Rituximab
Bendamustine
Sponsored by
Fate Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Diagnosis of B-cell lymphoma (BCL) as described below: Histologically documented BCL Previously untreated or no more than one prior systemic therapy for BCL At least one bi-dimensionally measurable lesion Subjects with >1 measurable lesion agreement to undergo a biopsy Capable of giving signed informed consent Age ≥ 18 years old Stated willingness to comply with study procedures through study duration Contraception use for women and men as defined in the protocol Negative serum pregnancy test within 7 days of treatment for women Key Exclusion Criteria: Prior anthracycline therapy Females who are pregnant or breastfeeding Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2 Evidence of insufficient organ function Currently receiving or likely to receive systemic immunosuppressive therapy Receipt of 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 HIV test Positive Hepatitis B (HBV) or Hepatitis C (HCV) test Live vaccine <6 weeks prior to start of conditioning Allergy to human albumin or dimethyl sulfoxide (DMSO)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Regimen A (FT596 in combination with standard schedule R-CHOP)

    Regimen B (FT596 in combination with alternate schedule R-CHOP)

    Arm Description

    FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.

    FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles

    Outcomes

    Primary Outcome Measures

    Incidence of dose-limiting toxicities within each dose escalation cohort
    Nature of dose-limiting toxicities within each dose escalation cohort
    Incidence, nature, and severity of adverse events (AEs) of FT596 in combination with R-CHOP in B-cell lymphoma previously untreated or no more than one previous line of therapy with severity determined according to NCI CTCAE, v5.0

    Secondary Outcome Measures

    Investigator-assessed complete response (CR)
    Proportion of subjects who achieve a complete response (CR) per Lugano 2014 classification
    Investigator-assessed objective-response rate (ORR)
    Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification
    Investigator-assessed duration of response (DOR)
    Duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification
    Investigator-assessed duration of complete response (DoCR)
    Duration from the first occurrence of a documented complete response (CR), per Lugano 2014 classification until the time of disease progression or relapse, or death from any cause, whichever occurs first
    Progression-free survival (PFS)
    Time from first dose of study treatment to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification
    Overall survival (OS)
    Time from first dose of study treatment to death from any cause
    Area Under the Plasma Concentration Time Curve (AUC) of FT596
    Assessed by the detection of FT596 in peripheral blood following FT596 administration.
    Maximum Plasma Concentration (Cmax) of FT596
    Assessed by the detection of FT596 in peripheral blood following FT596 administration.

    Full Information

    First Posted
    April 30, 2023
    Last Updated
    June 28, 2023
    Sponsor
    Fate Therapeutics
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05934097
    Brief Title
    FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
    Official Title
    A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    This study was withdrawn (Sponsor decision).
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    May 2026 (Anticipated)
    Study Completion Date
    May 2039 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fate Therapeutics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a Phase I study of FT596 in combination with two different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will consist of a dose-escalation stage followed by a dose-expansion stage.
    Detailed Description
    This is a Phase I study of FT596 in combination with 2 different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will evaluate both the clinical benefit of FT596 when combined with R-CHOP given on a standard or alternate schedule. Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. After safety and tolerability have been assessed to define the maximum tolerated dose (MTD) (or the maximum assessed dose [MAD] in the absence of dose limiting toxicities [DLTs] defining the MTD) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of FT596 in combination.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diffuse Large B Cell Lymphoma, Transformed Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    Subjects will be assigned to one of 2 treatment regimens corresponding to different schedules (standard or alternate) of R-CHOP
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Regimen A (FT596 in combination with standard schedule R-CHOP)
    Arm Type
    Experimental
    Arm Description
    FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.
    Arm Title
    Regimen B (FT596 in combination with alternate schedule R-CHOP)
    Arm Type
    Experimental
    Arm Description
    FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles
    Intervention Type
    Drug
    Intervention Name(s)
    FT596
    Intervention Description
    Dosing to be initiated at a dose no higher than highest tolerable dose in study FT596-101, intravenously
    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Intervention Description
    750 mg/m^2 intravenously
    Intervention Type
    Drug
    Intervention Name(s)
    Doxorubicin
    Intervention Description
    50 mg/m^2 intravenously
    Intervention Type
    Drug
    Intervention Name(s)
    Vincristine
    Intervention Description
    1.4 mg/m^2 (maximum dose 2 mg) intravenously
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisone
    Intervention Description
    100 mg orally
    Intervention Type
    Drug
    Intervention Name(s)
    Rituximab
    Other Intervention Name(s)
    Rituxan, Truxima, Ruxience
    Intervention Description
    375 mg/m^2 intravenously
    Intervention Type
    Drug
    Intervention Name(s)
    Bendamustine
    Other Intervention Name(s)
    Bendeka, Treanda
    Intervention Description
    90 mg/m^2 IV infusion
    Primary Outcome Measure Information:
    Title
    Incidence of dose-limiting toxicities within each dose escalation cohort
    Time Frame
    Day 21
    Title
    Nature of dose-limiting toxicities within each dose escalation cohort
    Time Frame
    Day 21
    Title
    Incidence, nature, and severity of adverse events (AEs) of FT596 in combination with R-CHOP in B-cell lymphoma previously untreated or no more than one previous line of therapy with severity determined according to NCI CTCAE, v5.0
    Time Frame
    Up to 5 years
    Secondary Outcome Measure Information:
    Title
    Investigator-assessed complete response (CR)
    Description
    Proportion of subjects who achieve a complete response (CR) per Lugano 2014 classification
    Time Frame
    Up to 2 years
    Title
    Investigator-assessed objective-response rate (ORR)
    Description
    Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification
    Time Frame
    Up to 2 years
    Title
    Investigator-assessed duration of response (DOR)
    Description
    Duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification
    Time Frame
    Up to 15 years
    Title
    Investigator-assessed duration of complete response (DoCR)
    Description
    Duration from the first occurrence of a documented complete response (CR), per Lugano 2014 classification until the time of disease progression or relapse, or death from any cause, whichever occurs first
    Time Frame
    Up to 15 years
    Title
    Progression-free survival (PFS)
    Description
    Time from first dose of study treatment to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification
    Time Frame
    Up to 15 years
    Title
    Overall survival (OS)
    Description
    Time from first dose of study treatment to death from any cause
    Time Frame
    Up to 15 years
    Title
    Area Under the Plasma Concentration Time Curve (AUC) of FT596
    Description
    Assessed by the detection of FT596 in peripheral blood following FT596 administration.
    Time Frame
    Cycles 1-6 (each cycle is 28 days): Days 1,8,11,15,18; and Post-Treatment Week 1, Week 2, Week 4, and Week 8
    Title
    Maximum Plasma Concentration (Cmax) of FT596
    Description
    Assessed by the detection of FT596 in peripheral blood following FT596 administration.
    Time Frame
    Cycles 1-6 (each cycle is 28 days): Days 1,8,11,15,18; and Post-Treatment Week 1, Week 2, Week 4, and Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: Diagnosis of B-cell lymphoma (BCL) as described below: Histologically documented BCL Previously untreated or no more than one prior systemic therapy for BCL At least one bi-dimensionally measurable lesion Subjects with >1 measurable lesion agreement to undergo a biopsy Capable of giving signed informed consent Age ≥ 18 years old Stated willingness to comply with study procedures through study duration Contraception use for women and men as defined in the protocol Negative serum pregnancy test within 7 days of treatment for women Key Exclusion Criteria: Prior anthracycline therapy Females who are pregnant or breastfeeding Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2 Evidence of insufficient organ function Currently receiving or likely to receive systemic immunosuppressive therapy Receipt of 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 HIV test Positive Hepatitis B (HBV) or Hepatitis C (HCV) test Live vaccine <6 weeks prior to start of conditioning Allergy to human albumin or dimethyl sulfoxide (DMSO)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fate Trial Disclosure
    Organizational Affiliation
    Fate Therapeutics
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

    We'll reach out to this number within 24 hrs