Clinical Trials /

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

NCT04245722

Description:

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.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies
  • 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

Clinical Trial IDs

  • ORG STUDY ID: FT596-101
  • NCT ID: NCT04245722

Conditions

  • Lymphoma, B-Cell
  • Chronic Lymphocytic Leukemia

Interventions

DrugSynonymsArms
FT596FT596 Monotherapy, CLL
CyclophosphamideFT596 Monotherapy, CLL
FludarabineFT596 Monotherapy, CLL
RituximabRituxan, MabTheraFT596 in Combination with Rituximab, Lymphoma
ObinutuzumabGazyvaFT596 in Combination with Obinutuzumab, CLL

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
FT596 Monotherapy, LymphomaExperimentalFT596 monotherapy in adult subjects with r/r B-cell Lymphoma
  • FT596
  • Cyclophosphamide
  • Fludarabine
FT596 in Combination with Rituximab, LymphomaExperimentalFT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
  • FT596
  • Cyclophosphamide
  • Fludarabine
  • Rituximab
FT596 in Combination with Obinutuzumab, LymphomaExperimentalFT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
  • FT596
  • Cyclophosphamide
  • Fludarabine
  • Obinutuzumab
FT596 Monotherapy, CLLExperimentalFT596 monotherapy in adult subjects with r/r CLL
  • FT596
  • Cyclophosphamide
  • Fludarabine
FT596 in Combination with Obinutuzumab, CLLExperimentalFT596 in combination with Obinutuzumab in adult subjects with r/r CLL
  • FT596
  • Cyclophosphamide
  • Fludarabine
  • Obinutuzumab

Eligibility 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 one prior systemic treatment 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 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

          -  Prior treatment with CD19 CAR-T therapy unless documented preservation of CD19 antigen
             is provided

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose-limiting toxicities within each dose level cohort
Time Frame:Day 29
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Investigator-assessed objective-response rate (ORR)
Time Frame:From baseline tumor assessment up to approximately 2 years after last dose of FT596
Safety Issue:
Description: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.
Measure:Investigator-assessed duration of objective response (DOR)
Time Frame:Up to 15 years
Safety Issue:
Description: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.
Measure:Investigator-assessed duration of complete response (DoCR)
Time Frame:Up to 15 years
Safety Issue:
Description:Defined as the duration from the first occurrence of a documented complete response (CR) per Lugano 2014 classification for lympohomas 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.
Measure:Progression-free survival (PFS)
Time Frame:Up to 15 years
Safety Issue:
Description: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 guidelinelines for CLL
Measure:Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause.
Time Frame:Up to 15 years
Safety Issue:
Description:
Measure: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, 43, 57
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Fate Therapeutics

Trial Keywords

  • Lymphoma
  • Leukemia

Last Updated

January 26, 2020