FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: FT596 Monotherapy, Lymphoma FT596 monotherapy in adult subjects with r/r B-cell Lymphoma |
Drug: FT596
Experimental Interventional Therapy
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
|
Experimental: FT596 in Combination with Rituximab, Lymphoma FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma |
Drug: FT596
Experimental Interventional Therapy
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Drug: Rituximab
Monoclonal Antibody
Other Names:
|
Experimental: FT596 in Combination with Obinutuzumab, Lymphoma FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma |
Drug: FT596
Experimental Interventional Therapy
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Drug: Obinutuzumab
Monoclonal Antibody
Other Names:
|
Experimental: FT596 Monotherapy, CLL FT596 monotherapy in adult subjects with r/r CLL |
Drug: FT596
Experimental Interventional Therapy
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
|
Experimental: FT596 in Combination with Obinutuzumab, CLL FT596 in combination with Obinutuzumab in adult subjects with r/r CLL |
Drug: FT596
Experimental Interventional Therapy
Drug: Cyclophosphamide
Lympho-conditioning agent
Drug: Fludarabine
Lympho-conditioning agent
Drug: Obinutuzumab
Monoclonal Antibody
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Investigator-assessed objective-response rate (ORR) [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.
- Investigator-assessed duration of objective response (DOR) [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.
- Investigator-assessed duration of complete response (DoCR) [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.
- Progression-free survival (PFS) [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
- Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause. [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 [Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29]
Eligibility Criteria
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
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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
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The University of Chicago | Chicago | Illinois | United States | 60637 |
2 | University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | United States | 55455 |
3 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
4 | NYU Langone Health | New York | New York | United States | 10016 |
5 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
6 | Sarah Cannon Research Institute (Tennessee Oncology) | Nashville | Tennessee | United States | 37203 |
7 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
8 | SCRI-TTI | San Antonio | Texas | United States | 78229 |
9 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Fate Therapeutics
Investigators
- Study Director: Rebecca Elstrom, MD, Fate Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
- FT596-101