FT516 in Subjects With Advanced Hematologic Malignancies
Phase 1
Terminated
- Conditions
- Acute Myelogenous LeukemiaB-cell Lymphoma
- Interventions
- Registration Number
- NCT04023071
- Lead Sponsor
- Fate Therapeutics
- Brief Summary
This is a Phase 1/1b dose-finding study of FT516 as monotherapy in acute myeloid leukemia (AML) and in combination with CD20 directed monoclonal antibodies in B-cell lymphoma. The study includes three stages: dose escalation, safety confirmation, and dose expansion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FT516 in Combination with Monoclonal Antibodies Cyclophosphamide FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule Cyclophosphamide FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 Monotherapy IL-2 FT516 monotherapy in adult subjects with r/r AML. FT516 in Combination with Monoclonal Antibodies Rituximab FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies Obinutuzumab FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 Monotherapy FT516 FT516 monotherapy in adult subjects with r/r AML. FT516 Monotherapy Fludarabine FT516 monotherapy in adult subjects with r/r AML. FT516 Monotherapy Cyclophosphamide FT516 monotherapy in adult subjects with r/r AML. FT516 in Combination with Monoclonal Antibodies IL-2 FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies Fludarabine FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule Rituximab FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule FT516 FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule Obinutuzumab FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule Fludarabine FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule IL-2 FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning FT516 Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning Rituximab Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning Obinutuzumab Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning IL-2 Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning Bendamustine Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab. FT516 in Combination with Monoclonal Antibodies FT516 FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
- Primary Outcome Measures
Name Time Method Incidence, nature, and severity of AEs, of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma. Up to 5 years The incidence of subjects with Dose Limiting Toxicities within each dose level cohort. Day 29
- Secondary Outcome Measures
Name Time Method FT516 pharmacokinetic data Cycle 1 and Cycle 2 Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29, and Cycle 2 Day 43 and Cycle 2 Day 57. Percentage of donor DNA measured at each timepoint
Investigator-assessed anti-tumor activity of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma. Cycle 2 Day 29
Trial Locations
- Locations (7)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Mayo Clinic
🇺🇸Phoenix, Arizona, United States
UC San Diego
🇺🇸San Diego, California, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
University of Minnesota Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
University of Colorado, Denver
🇺🇸Denver, Colorado, United States