Back to resultsFT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies
Primary Purpose
Lymphoma, B-Cell, Chronic Lymphocytic Leukemia
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FT596
Cyclophosphamide
Fludarabine
Rituximab
Obinutuzumab
Bendamustine
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring Lymphoma, Leukemia
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 two prior systemic treatment regimens
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
- 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
Sites / Locations
- The University of Chicago
- University of Minnesota Masonic Cancer Center
- Washington University School of Medicine
- NYU Langone Health
- Memorial Sloan Kettering Cancer Center
- Sarah Cannon Research Institute (Tennessee Oncology)
- MD Anderson Cancer Center
- SCRI-TTI
- Swedish Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
FT596 Monotherapy, Lymphoma
FT596 in Combination with Rituximab, Lymphoma
FT596 in Combination with Obinutuzumab, Lymphoma
FT596 Monotherapy, CLL
FT596 in Combination with Obinutuzumab, CLL
Arm Description
FT596 monotherapy in adult subjects with r/r B-cell Lymphoma
FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
FT596 monotherapy in adult subjects with r/r CLL
FT596 in combination with Obinutuzumab in adult subjects with r/r CLL
Outcomes
Primary Outcome Measures
Incidence of dose-limiting toxicities within each dose level cohort
Nature of dose-limiting toxicities within each dose level cohort
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, with severity determined according to NCI CTCAE, v5.0
Secondary Outcome Measures
Investigator-assessed objective-response rate (ORR)
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.
Investigator-assessed duration of objective response (DOR)
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.
Investigator-assessed duration of complete response (DoCR)
Defined as the duration from the first occurrence of a documented complete response (CR) per Lugano 2014 classification for lymphomas 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.
Progression-free survival (PFS)
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 guidelines for CLL
Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04245722
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 19, 2020 (Actual)
Primary Completion Date
May 2024 (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
Yes
5. Study Description
Brief Summary
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.
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
Keywords
Lymphoma, Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FT596 Monotherapy, Lymphoma
Arm Type
Experimental
Arm Description
FT596 monotherapy in adult subjects with r/r B-cell Lymphoma
Arm Title
FT596 in Combination with Rituximab, Lymphoma
Arm Type
Experimental
Arm Description
FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
Arm Title
FT596 in Combination with Obinutuzumab, Lymphoma
Arm Type
Experimental
Arm Description
FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
Arm Title
FT596 Monotherapy, CLL
Arm Type
Experimental
Arm Description
FT596 monotherapy in adult subjects with r/r CLL
Arm Title
FT596 in Combination with Obinutuzumab, CLL
Arm Type
Experimental
Arm Description
FT596 in combination with Obinutuzumab in adult subjects with r/r CLL
Intervention Type
Drug
Intervention Name(s)
FT596
Intervention Description
Experimental Interventional Therapy
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Lympho-conditioning agent
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Lympho-conditioning agent
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, Truxima, Ruxience
Intervention Description
Monoclonal Antibody
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
Gazyva
Intervention Description
Monoclonal Antibody
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Bendeka, Treanda
Intervention Description
Conditioning agent
Primary Outcome Measure Information:
Title
Incidence of dose-limiting toxicities within each dose level cohort
Time Frame
Day 29
Title
Nature of dose-limiting toxicities within each dose level cohort
Time Frame
Day 29
Title
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, with severity determined according to NCI CTCAE, v5.0
Time Frame
Up to 15 years
Secondary Outcome Measure Information:
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 for lymphomas, a partial remission (PR) or complete remission (CR) per revised iwCLL guidelines for CLL.
Time Frame
From baseline tumor assessment up to approximately 2 years after last dose of FT596
Title
Investigator-assessed duration of objective response (DOR)
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.
Time Frame
Up to 15 years
Title
Investigator-assessed duration of complete response (DoCR)
Description
Defined as the duration from the first occurrence of a documented complete response (CR) per Lugano 2014 classification for lymphomas 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.
Time Frame
Up to 15 years
Title
Progression-free survival (PFS)
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 guidelines for CLL
Time Frame
Up to 15 years
Title
Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause.
Time Frame
Up to 15 years
Title
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
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 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 two prior systemic treatment regimens
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
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
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
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Minnesota Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Sarah Cannon Research Institute (Tennessee Oncology)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
SCRI-TTI
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30082067
Citation
Li Y, Hermanson DL, Moriarity BS, Kaufman DS. Human iPSC-Derived Natural Killer Cells Engineered with Chimeric Antigen Receptors Enhance Anti-tumor Activity. Cell Stem Cell. 2018 Aug 2;23(2):181-192.e5. doi: 10.1016/j.stem.2018.06.002. Epub 2018 Jun 28.
Results Reference
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FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies
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