Clinical Trials /

FT819 in Subjects With B-cell Malignancies

NCT04629729

Description:

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.

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

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: FT819 in Subjects With B-cell Malignancies
  • Official Title: A Phase I Study of FT819 in Subjects With B-cell Malignancies

Clinical Trial IDs

  • ORG STUDY ID: FT819-101
  • NCT ID: NCT04629729

Conditions

  • Lymphoma, B-Cell
  • Chronic Lymphocytic Leukemia
  • Precursor B-Cell Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
FT819FT819 Single-Dose Monotherapy, B-ALL
CyclophosphamideFT819 Single-Dose Monotherapy, B-ALL
FludarabineFT819 Single-Dose Monotherapy, B-ALL
IL-2Interleukin-2FT819 Single-Dose in Combination with IL-2, B-ALL

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
FT819 Single-Dose Monotherapy, B-Cell LymphomaExperimentalFT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
  • FT819
  • Cyclophosphamide
  • Fludarabine
FT819 Single-Dose in Combination with IL-2, B-Cell LymphomaExperimentalFT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
  • FT819
  • Cyclophosphamide
  • Fludarabine
  • IL-2
FT819 Step Fractionated Monotherapy, B-Cell LymphomaExperimentalFT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
  • FT819
  • Cyclophosphamide
  • Fludarabine
FT819 Single-Dose Monotherapy, CLLExperimentalFT819 single-dose monotherapy in adult subjects with r/r CLL
  • FT819
  • Cyclophosphamide
  • Fludarabine
FT819 Single-Dose in Combination with IL-2, CLLExperimentalFT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
  • FT819
  • Cyclophosphamide
  • Fludarabine
  • IL-2
FT819 Step Fractionated Monotherapy, CLLExperimentalFT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
  • FT819
  • Cyclophosphamide
  • Fludarabine
FT819 Single-Dose Monotherapy, B-ALLExperimentalFT819 single-dose monotherapy in adult subjects with r/r B-ALL
  • FT819
  • Cyclophosphamide
  • Fludarabine
FT819 Single-Dose in Combination with IL-2, B-ALLExperimentalFT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
  • FT819
  • Cyclophosphamide
  • Fludarabine
  • IL-2
FT819 Step Fractionated Monotherapy, B-ALLExperimentalFT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
  • FT819
  • Cyclophosphamide
  • Fludarabine

Eligibility Criteria

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

Primary Outcome Measures

Measure:Incidence and nature 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 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
Safety Issue:
Description:
Measure:Investigator-assessed objective-response rate (ORR)
Time Frame:From baseline assessment up to approximately 2 years after last dose of FT819
Safety Issue:
Description:
Measure:For BCL and CLL Only: Investigator-assessed duration of objective response (DOR)
Time Frame:Up to 15 years
Safety Issue:
Description:
Measure:For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)
Time Frame:Up to 15 years
Safety Issue:
Description:
Measure:For BCL and CLL Only: Progression-free survival (PFS)
Time Frame:Up to 15 years
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Up to 15 years
Safety Issue:
Description:
Measure: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
Safety Issue:
Description: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
Measure:For B-ALL Only: Investigator-assessed relapse-free survival (RFS)
Time Frame:Up to 15 years
Safety Issue:
Description:

Details

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

Trial Keywords

  • Lymphoma
  • Leukemia
  • BCL
  • CLL
  • B-ALL
  • CAR-T
  • cellular therapy

Last Updated

November 16, 2020