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FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101)

Primary Purpose

Relapsed/Refractory B-Cell Lymphoma

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
FT522
Rituximab
Cyclophosphamide
Fludarabine
Bendamustine
Sponsored by
Fate Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory B-Cell Lymphoma

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of B-cell lymphoma (BCL) as: histologically documented lymphomas expected to express CD19 and CD20, including Grades 1 to 3B follicular lymphoma (FL), transformed indolent non-Hodgkin lymphoma (tNHL), diffuse large B-cell lymphoma (DLBCL) [not otherwise specified], high-grade BCL, and primary mediastinal BCL; R/R disease following at least 1 prior systemic regimen containing an anti-CD20 monoclonal antibody (mAb) for which the participant has no available curative treatment options; evaluable F-fluorodeoxyglucose (FDG)-avid disease, or measurable disease defined by at least one bi dimensionally measurable lesion Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception Exclusion Criteria: 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 any biological therapy, chemotherapy (except for rituximab), or any investigational therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or localized radiation therapy to a target lesion within 14 days prior to Day 1 Currently receiving or likely to require systemic immunosuppressive therapy, e.g., prednisone >5 mg daily, for any reason from Day -5 to Day 29, with the exception of corticosteroids as a pre medication required for conditioning chemotherapy or rituximab Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic chimeric antigen receptor (CAR) T-cell therapy within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host disease (GvHD) therapy Receipt of an allograft organ transplant Non-malignant central nervous system (CNS) disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment Clinically significant cardiovascular disease Clinically significant infections Receipt of a live vaccine <6 weeks prior to start of study intervention Known allergy to human albumin or DMSO Any medical condition or clinical laboratory abnormality that per investigator or medical monitor judgement, precludes safe participation in and completion of the study, or that could affect compliance with protocol conduct or interpretation of results

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Regimen A

    Regimen B

    Arm Description

    Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) with chemotherapy.

    Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) without chemotherapy.

    Outcomes

    Primary Outcome Measures

    Number of participants with dose limiting toxicities (DLTs)
    The number of participants experiencing ≥1 DLT will be reported.
    Severity of DLTs
    The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).

    Secondary Outcome Measures

    Overall Response Rate (ORR)
    Participants will be classified into the following tumor response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE) according to the Lugano 2014 criteria. The best overall response (BOR) will be summarized for the efficacy evaluable population. ORR is defined as the percentage of participants who achieve a PR or better during the study prior to any subsequent off-protocol anti-cancer therapy.
    Duration of Response (DOR)
    The DOR is defined as the time from first objective response to disease progression or death from any cause.
    Duration of Complete Response (DOCR)
    The DOCR is defined as the time from first CR to disease progression or death from any cause.
    Progression-Free Survival (PFS)
    PFS is defined as the time from first study intervention to progressive disease or death from any cause.
    Overall Survival (OS)
    OS is defined as the time from first dose of study intervention to death from any cause.
    Area Under the Plasma-Concentration Time Curve (AUC) of FT522
    The plasma AUC of FT522 will be reported.
    Maximum Plasma Concentration (Cmax) of FT522
    The plasma Cmax of FT522 will be reported.

    Full Information

    First Posted
    July 10, 2023
    Last Updated
    July 10, 2023
    Sponsor
    Fate Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05950334
    Brief Title
    FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101)
    Official Title
    A Phase 1 Study of FT522 in Combination With Rituximab in Participants With Relapsed/Refractory B-Cell Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 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
    Yes

    5. Study Description

    Brief Summary
    This is a phase 1 study of FT522 administered with rituximab in participants with relapsed/refractory B-cell lymphoma (R/R BCL). The primary objectives of the study are to evaluate the safety and tolerability of FT522 in combination with rituximab, and to determine the recommended phase 2 dose (RP2D) of FT522 in combination with rituximab; each objective will be assessed with or without conditioning chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapsed/Refractory B-Cell Lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Sequential Assignment
    Model Description
    Participants will be enrolled first into a dose-escalation stage, followed by a dose optimization stage, and a dose-expansion stage.
    Masking
    None (Open Label)
    Masking Description
    The initial dose escalation stage of the study is nonrandomized; the dose optimization stage is randomized; the dose expansion stage is nonrandomized.
    Allocation
    Non-Randomized
    Enrollment
    322 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Regimen A
    Arm Type
    Experimental
    Arm Description
    Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) with chemotherapy.
    Arm Title
    Regimen B
    Arm Type
    Experimental
    Arm Description
    Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) without chemotherapy.
    Intervention Type
    Drug
    Intervention Name(s)
    FT522
    Intervention Description
    FT522 drug product is administered as an intravenous infusion on Days 1, 4 and 8 of a treatment cycle.
    Intervention Type
    Drug
    Intervention Name(s)
    Rituximab
    Other Intervention Name(s)
    RITUXAN, TRUXIMA, RUXIENCE, RIABNI
    Intervention Description
    Rituximab will be administered as an IV infusion on Day -4 of the treatment cycle.
    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Intervention Description
    Cyclophosphamide will be administered as an IV infusion at a dose of 500 mg/m^2 on Day -5, Day -4, and Day -3 of the treatment cycle.
    Intervention Type
    Drug
    Intervention Name(s)
    Fludarabine
    Intervention Description
    Fludarabine will be administered as an IV infusion at a dose of 30 mg/m^2 on Day -5, Day -4, and Day -3 of the treatment cycle.
    Intervention Type
    Drug
    Intervention Name(s)
    Bendamustine
    Intervention Description
    Bendamustine will be administered as an IV infusion at a dose of 90 mg/m^2 on Day -5 and Day -4 of the treatment cycle. Bendamustine may be administered as an alternative to cyclophosphamide/fludarabine.
    Primary Outcome Measure Information:
    Title
    Number of participants with dose limiting toxicities (DLTs)
    Description
    The number of participants experiencing ≥1 DLT will be reported.
    Time Frame
    From Day 1 through Day 29 of Cycle 1
    Title
    Severity of DLTs
    Description
    The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).
    Time Frame
    From Day 1 through Day 29 of Cycle 1
    Secondary Outcome Measure Information:
    Title
    Overall Response Rate (ORR)
    Description
    Participants will be classified into the following tumor response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE) according to the Lugano 2014 criteria. The best overall response (BOR) will be summarized for the efficacy evaluable population. ORR is defined as the percentage of participants who achieve a PR or better during the study prior to any subsequent off-protocol anti-cancer therapy.
    Time Frame
    Up to approximately 24 months
    Title
    Duration of Response (DOR)
    Description
    The DOR is defined as the time from first objective response to disease progression or death from any cause.
    Time Frame
    Up to approximately 18 months
    Title
    Duration of Complete Response (DOCR)
    Description
    The DOCR is defined as the time from first CR to disease progression or death from any cause.
    Time Frame
    Up to approximately 18 months
    Title
    Progression-Free Survival (PFS)
    Description
    PFS is defined as the time from first study intervention to progressive disease or death from any cause.
    Time Frame
    Up to approximately 18 months
    Title
    Overall Survival (OS)
    Description
    OS is defined as the time from first dose of study intervention to death from any cause.
    Time Frame
    Up to approximately 18 months
    Title
    Area Under the Plasma-Concentration Time Curve (AUC) of FT522
    Description
    The plasma AUC of FT522 will be reported.
    Time Frame
    Cycle 1, Up to Day 29
    Title
    Maximum Plasma Concentration (Cmax) of FT522
    Description
    The plasma Cmax of FT522 will be reported.
    Time Frame
    Cycle 1, Up to Day 29

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of B-cell lymphoma (BCL) as: histologically documented lymphomas expected to express CD19 and CD20, including Grades 1 to 3B follicular lymphoma (FL), transformed indolent non-Hodgkin lymphoma (tNHL), diffuse large B-cell lymphoma (DLBCL) [not otherwise specified], high-grade BCL, and primary mediastinal BCL; R/R disease following at least 1 prior systemic regimen containing an anti-CD20 monoclonal antibody (mAb) for which the participant has no available curative treatment options; evaluable F-fluorodeoxyglucose (FDG)-avid disease, or measurable disease defined by at least one bi dimensionally measurable lesion Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception Exclusion Criteria: 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 any biological therapy, chemotherapy (except for rituximab), or any investigational therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or localized radiation therapy to a target lesion within 14 days prior to Day 1 Currently receiving or likely to require systemic immunosuppressive therapy, e.g., prednisone >5 mg daily, for any reason from Day -5 to Day 29, with the exception of corticosteroids as a pre medication required for conditioning chemotherapy or rituximab Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic chimeric antigen receptor (CAR) T-cell therapy within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host disease (GvHD) therapy Receipt of an allograft organ transplant Non-malignant central nervous system (CNS) disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment Clinically significant cardiovascular disease Clinically significant infections Receipt of a live vaccine <6 weeks prior to start of study intervention Known allergy to human albumin or DMSO Any medical condition or clinical laboratory abnormality that per investigator or medical monitor judgement, precludes safe participation in and completion of the study, or that could affect compliance with protocol conduct or interpretation of results

    12. IPD Sharing Statement

    Learn more about this trial

    FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101)

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