Study Stopped
The study was terminated by the Sponsor.
FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies
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
1 other identifier
interventional
98
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2020
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2020
CompletedFirst Posted
Study publicly available on registry
January 29, 2020
CompletedStudy Start
First participant enrolled
March 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2023
CompletedOctober 26, 2023
October 1, 2023
3.5 years
January 18, 2020
October 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of dose-limiting toxicities within each dose level cohort
Day 29
Nature of dose-limiting toxicities within each dose level cohort
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
Up to 15 years
Secondary Outcomes (6)
Investigator-assessed objective-response rate (ORR)
From baseline tumor assessment up to approximately 2 years after last dose of FT596
Investigator-assessed duration of objective response (DOR)
Up to 15 years
Investigator-assessed duration of complete response (DoCR)
Up to 15 years
Progression-free survival (PFS)
Up to 15 years
Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause.
Up to 15 years
- +1 more secondary outcomes
Study Arms (5)
FT596 Monotherapy, Lymphoma
EXPERIMENTALFT596 monotherapy in adult subjects with r/r B-cell Lymphoma
FT596 in Combination with Rituximab, Lymphoma
EXPERIMENTALFT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
FT596 in Combination with Obinutuzumab, Lymphoma
EXPERIMENTALFT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
FT596 Monotherapy, CLL
EXPERIMENTALFT596 monotherapy in adult subjects with r/r CLL
FT596 in Combination with Obinutuzumab, CLL
EXPERIMENTALFT596 in combination with Obinutuzumab in adult subjects with r/r CLL
Interventions
Experimental Interventional Therapy
Lympho-conditioning agent
Lympho-conditioning agent
Monoclonal Antibody
Monoclonal Antibody
Conditioning agent
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
The University of Chicago
Chicago, Illinois, 60637, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
NYU Langone Health
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
SCRI-TTI
San Antonio, Texas, 78229, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Related Publications (2)
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.
PMID: 30082067BACKGROUNDGhobadi A, Bachanova V, Patel K, Park JH, Flinn I, Riedell PA, Bachier C, Diefenbach CS, Wong C, Bickers C, Wong L, Patel D, Goodridge J, Denholt M, Valamehr B, Elstrom RL, Strati P. Induced pluripotent stem-cell-derived CD19-directed chimeric antigen receptor natural killer cells in B-cell lymphoma: a phase 1, first-in-human trial. Lancet. 2025 Jan 11;405(10473):127-136. doi: 10.1016/S0140-6736(24)02462-0.
PMID: 39798981DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fate Trial Disclosure
Fate Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2020
First Posted
January 29, 2020
Study Start
March 19, 2020
Primary Completion
September 27, 2023
Study Completion
September 27, 2023
Last Updated
October 26, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share