search
Back to results

FT819 in Subjects With B-cell Malignancies

Primary Purpose

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

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FT819
Cyclophosphamide
Fludarabine
IL-2
Bendamustine
Sponsored by
Fate Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring Lymphoma, Leukemia, BCL, CLL, B-ALL, CAR-T, cellular therapy

Eligibility Criteria

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

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 and 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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • UCLA Ronald Reagan Medical CenterRecruiting
  • Stanford Cancer InstituteRecruiting
  • University of IowaRecruiting
  • The University of Kansas Medical CenterRecruiting
  • Norton Cancer Institute, St. Matthews CampusRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Hackensack University Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Oregon Health & Sciences UniversityRecruiting
  • MD Anderson Cancer CenterRecruiting
  • University of Wisconsin-MadisonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

FT819 Single-Dose Monotherapy, B-Cell Lymphoma

FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma

FT819 Step Fractionated Monotherapy, B-Cell Lymphoma

FT819 Single-Dose Monotherapy, CLL

FT819 Single-Dose in Combination with IL-2, CLL

FT819 Step Fractionated Monotherapy, CLL

FT819 Single-Dose Monotherapy, B-ALL

FT819 Single-Dose in Combination with IL-2, B-ALL

FT819 Step Fractionated Monotherapy, B-ALL

FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma

FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL

FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL

Arm Description

FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma

FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma

FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma

FT819 single-dose monotherapy in adult subjects with r/r CLL

FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL

FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL

FT819 single-dose monotherapy in adult subjects with r/r B-ALL

FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL

FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL

FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma

FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL

FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL

Outcomes

Primary Outcome Measures

Incidence and nature of dose-limiting toxicities within each dose level cohort
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

Secondary Outcome Measures

Investigator-assessed objective-response rate (ORR)
For BCL and CLL Only: Investigator-assessed duration of objective response (DOR)
For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)
For BCL and CLL Only: Progression-free survival (PFS)
Overall survival (OS)
Determination of the pharmacokinetics of FT819 cells in peripheral blood.
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
For B-ALL Only: Investigator-assessed relapse-free survival (RFS)

Full Information

First Posted
November 10, 2020
Last Updated
May 1, 2023
Sponsor
Fate Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT04629729
Brief Title
FT819 in Subjects With B-cell Malignancies
Official Title
A Phase I Study of FT819 in Subjects With B-cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell, Chronic Lymphocytic Leukemia, Precursor B-Cell Acute Lymphoblastic Leukemia
Keywords
Lymphoma, Leukemia, BCL, CLL, B-ALL, CAR-T, cellular therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
396 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FT819 Single-Dose Monotherapy, B-Cell Lymphoma
Arm Type
Experimental
Arm Description
FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
Arm Title
FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
Arm Type
Experimental
Arm Description
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
Arm Title
FT819 Step Fractionated Monotherapy, B-Cell Lymphoma
Arm Type
Experimental
Arm Description
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
Arm Title
FT819 Single-Dose Monotherapy, CLL
Arm Type
Experimental
Arm Description
FT819 single-dose monotherapy in adult subjects with r/r CLL
Arm Title
FT819 Single-Dose in Combination with IL-2, CLL
Arm Type
Experimental
Arm Description
FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
Arm Title
FT819 Step Fractionated Monotherapy, CLL
Arm Type
Experimental
Arm Description
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
Arm Title
FT819 Single-Dose Monotherapy, B-ALL
Arm Type
Experimental
Arm Description
FT819 single-dose monotherapy in adult subjects with r/r B-ALL
Arm Title
FT819 Single-Dose in Combination with IL-2, B-ALL
Arm Type
Experimental
Arm Description
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
Arm Title
FT819 Step Fractionated Monotherapy, B-ALL
Arm Type
Experimental
Arm Description
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
Arm Title
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma
Arm Type
Experimental
Arm Description
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
Arm Title
FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL
Arm Type
Experimental
Arm Description
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
Arm Title
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL
Arm Type
Experimental
Arm Description
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
Intervention Type
Drug
Intervention Name(s)
FT819
Intervention Description
Experimental Interventional Therapy
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Lympho-conditioning agent
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
Fludara
Intervention Description
Lympho-conditioning agent
Intervention Type
Drug
Intervention Name(s)
IL-2
Other Intervention Name(s)
Interleukin-2
Intervention Description
Biologic response modifier
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Bendeka, Treanda
Intervention Description
Lympho-conditioning agent
Primary Outcome Measure Information:
Title
Incidence and nature of dose-limiting toxicities within each dose level cohort
Time Frame
Up to Day 29
Title
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
Secondary Outcome Measure Information:
Title
Investigator-assessed objective-response rate (ORR)
Time Frame
Up to approximately 2 years after last dose of FT819
Title
For BCL and CLL Only: Investigator-assessed duration of objective response (DOR)
Time Frame
Up to 15 years
Title
For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)
Time Frame
Up to 15 years
Title
For BCL and CLL Only: Progression-free survival (PFS)
Time Frame
Up to 15 years
Title
Overall survival (OS)
Time Frame
Up to 15 years
Title
Determination of the pharmacokinetics of FT819 cells in peripheral blood.
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
Time Frame
Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29
Title
For B-ALL Only: Investigator-assessed relapse-free survival (RFS)
Time Frame
Up to 15 years

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, 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 and 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fate Trial Disclosure
Phone
866-875-1800
Email
FateTrialDisclosure@fatetherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fate Trial Disclosure
Organizational Affiliation
Fate Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA Ronald Reagan Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Cancer Institute, St. Matthews Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://doi.org/10.1182/blood-2019-130584
Description
FT819: Translation of Off-the-Shelf TCR-Less Trac-1XX CAR-T Cells in Support of First-of-Kind Phase I Clinical Trial
URL
https://cancerres.aacrjournals.org/content/80/16_Supplement/3245
Description
AACR 2020 Poster # 3245
URL
https://fatetherapeutics.com/wp-content/uploads/2022/12/2000-FT81989.pdf
Description
ASH 2022 Poster Presentation
URL
https://ash.confex.com/ash/2022/webprogram/Paper167194.html
Description
ASH 2022 Abstract

Learn more about this trial

FT819 in Subjects With B-cell Malignancies

We'll reach out to this number within 24 hrs