- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04245722
FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies
October 25, 2023 updated by: Fate Therapeutics
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Prutha Shah
- Phone Number: 858-875-1800
- Email: clinical@fatetherapeutics.com
Study Contact Backup
- Name: Jamuna Thimmarayappa
- Phone Number: 858-875-1800
- Email: clinical@fatetherapeutics.com
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- The University of Chicago
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota Masonic Cancer Center
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute (Tennessee Oncology)
-
-
Texas
-
Houston, Texas, United States, 77030
- Md Anderson Cancer Center
-
San Antonio, Texas, United States, 78229
- SCRI-TTI
-
-
Washington
-
Seattle, Washington, United States, 98104
- Swedish Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FT596 Monotherapy, Lymphoma
FT596 monotherapy in adult subjects with r/r B-cell Lymphoma
|
Conditioning agent
Other Names:
Lympho-conditioning agent
Lympho-conditioning agent
Experimental Interventional Therapy
|
Experimental: FT596 in Combination with Rituximab, Lymphoma
FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
|
Monoclonal Antibody
Other Names:
Conditioning agent
Other Names:
Lympho-conditioning agent
Lympho-conditioning agent
Experimental Interventional Therapy
|
Experimental: FT596 in Combination with Obinutuzumab, Lymphoma
FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
|
Monoclonal Antibody
Other Names:
Conditioning agent
Other Names:
Lympho-conditioning agent
Lympho-conditioning agent
Experimental Interventional Therapy
|
Experimental: FT596 Monotherapy, CLL
FT596 monotherapy in adult subjects with r/r CLL
|
Conditioning agent
Other Names:
Lympho-conditioning agent
Lympho-conditioning agent
Experimental Interventional Therapy
|
Experimental: FT596 in Combination with Obinutuzumab, CLL
FT596 in combination with Obinutuzumab in adult subjects with r/r CLL
|
Monoclonal Antibody
Other Names:
Conditioning agent
Other Names:
Lympho-conditioning agent
Lympho-conditioning agent
Experimental Interventional Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of dose-limiting toxicities within each dose level cohort
Time Frame: Day 29
|
Day 29
|
Nature of dose-limiting toxicities within each dose level cohort
Time Frame: Day 29
|
Day 29
|
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
|
Up to 15 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigator-assessed objective-response rate (ORR)
Time Frame: From baseline tumor assessment up to approximately 2 years after last dose of FT596
|
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.
|
From baseline tumor assessment up to approximately 2 years after last dose of FT596
|
Investigator-assessed duration of objective response (DOR)
Time Frame: Up to 15 years
|
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.
|
Up to 15 years
|
Investigator-assessed duration of complete response (DoCR)
Time Frame: Up to 15 years
|
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.
|
Up to 15 years
|
Progression-free survival (PFS)
Time Frame: Up to 15 years
|
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
|
Up to 15 years
|
Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause.
Time Frame: Up to 15 years
|
Up to 15 years
|
|
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
|
Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Fate Trial Disclosure, Fate Therapeutics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 19, 2020
Primary Completion (Actual)
September 27, 2023
Study Completion (Actual)
September 27, 2023
Study Registration Dates
First Submitted
January 18, 2020
First Submitted That Met QC Criteria
January 26, 2020
First Posted (Actual)
January 29, 2020
Study Record Updates
Last Update Posted (Actual)
October 26, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Disease Attributes
- Leukemia, B-Cell
- Chronic Disease
- Lymphoma
- Lymphoma, B-Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Immunological
- Cyclophosphamide
- Bendamustine Hydrochloride
- Rituximab
- Fludarabine
- Obinutuzumab
Other Study ID Numbers
- FT596-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphoma, B-Cell
-
Iksuda Therapeutics Ltd.RecruitingFollicular Lymphoma | B-cell Lymphoma | Mantle Cell Lymphoma | Diffuse Large B Cell Lymphoma | B-cell Non-Hodgkin LymphomaAustralia, Canada, United States
-
Nathan DenlingerBristol-Myers SquibbRecruitingB-Cell Non-Hodgkin Lymphoma-Recurrent | Diffuse Large B-Cell Lymphoma-Recurrent | Follicular Lymphoma-Recurrent | High Grade B-Cell Lymphoma-Recurrent | Primary Mediastinal Large B-Cell Lymphoma-Recurrent | Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent and other conditionsUnited States
-
University of ChicagoMerck Sharp & Dohme LLCRecruitingLymphoma | Lymphoma, B-Cell | B Cell Lymphoma | Diffuse Large B Cell Lymphoma | High-grade B-cell LymphomaUnited States
-
AstraZenecaRecruitingFollicular Lymphoma | Diffuse Large B Cell Lymphoma | High-grade B-cell Lymphoma | B-cell Non Hodgkin LymphomaKorea, Republic of, United States, Japan, Australia, Taiwan
-
Curocell Inc.RecruitingHigh-grade B-cell Lymphoma | Diffuse Large B-cell Lymphoma (DLBCL) | Primary Mediastinal Large B-Cell Lymphoma (PMBCL) | Transformed Follicular Lymphoma (TFL) | Refractory Large B-cell Lymphoma | Relapsed Large B-cell LymphomaKorea, Republic of
-
Memorial Sloan Kettering Cancer CenterRecruitingLymphoma | Lymphoma, B-Cell | DLBCL - Diffuse Large B Cell Lymphoma | Large B-cell Lymphoma | Large-cell Lymphoma | Mediastinal B-Cell Diffuse Large Cell LymphomaUnited States
-
Massachusetts General HospitalVarian Medical SystemsRecruitingLymphoma, B-Cell | Follicular Lymphoma | Mantle Cell Lymphoma | Diffuse Large B Cell Lymphoma | Refractory Lymphoma | High-grade B-cell Lymphoma | Relapsed Cancer | Mediastinal Large B-cell LymphomaUnited States
-
Dana-Farber Cancer InstituteBayer; AbbVieActive, not recruitingDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaUnited States
-
Weill Medical College of Cornell UniversityEpizyme, Inc.; American Society of Clinical Oncology; Applebaum FoundationRecruitingFollicular Lymphoma | Mantle Cell Lymphoma | Diffuse Large B Cell Lymphoma | B-Cell LymphomaUnited States
-
University Hospital Southampton NHS Foundation...Hoffmann-La RocheTerminatedDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaUnited Kingdom
Clinical Trials on Rituximab
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingEBV-Related Post-Transplant Lymphoproliferative Disorder | Monomorphic Post-Transplant Lymphoproliferative Disorder | Polymorphic Post-Transplant Lymphoproliferative Disorder | Recurrent Monomorphic Post-Transplant Lymphoproliferative Disorder | Recurrent Polymorphic Post-Transplant Lymphoproliferative... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingRecurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Mantle Cell Lymphoma | Recurrent Marginal Zone Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Recurrent Small Lymphocytic Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Grade 3a Follicular... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingAnn Arbor Stage I Grade 1 Follicular Lymphoma | Ann Arbor Stage I Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 1 Follicular Lymphoma | Ann Arbor Stage II Grade 2 Follicular LymphomaUnited States
-
National Cancer Institute (NCI)CompletedAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Small Lymphocytic Lymphoma | Prolymphocytic Leukemia | Recurrent Chronic Lymphocytic LeukemiaUnited States
-
National Cancer Institute (NCI)Celgene CorporationActive, not recruitingAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
-
PfizerCompletedRheumatoid ArthritisUnited States, Australia, Canada, Israel, Mexico, Colombia, Germany, Russian Federation, South Africa, United Kingdom
-
Mabion SAParexelWithdrawn
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Mantle Cell Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaUnited States