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出境医 / 临床实验 / FT516 in Subjects With Advanced Hematologic Malignancies
FT516 in Subjects With Advanced Hematologic Malignancies
Study Description
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 will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Myelogenous Leukemia B-cell Lymphoma | Drug: FT516 Drug: Rituximab Drug: Obinutuzumab Drug: Cyclophosphamide Drug: Fludarabine Drug: IL-2 | Phase 1 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 72 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory B-Cell Lymphoma |
| Actual Study Start Date : | October 4, 2019 |
| Estimated Primary Completion Date : | July 2021 |
| Estimated Study Completion Date : | May 2026 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: FT516 Monotherapy
FT516 monotherapy in adult subjects with r/r AML.
|
Drug: FT516
Experimental Interventional Therapy
Drug: Cyclophosphamide Lympho-conditioning agent
Drug: Fludarabine Lympho-conditioning agent
Drug: IL-2 Biologic response modifier
|
|
Experimental: FT516 in Combination with Monoclonal Antibodies
FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
|
Drug: FT516
Experimental Interventional Therapy
Drug: Rituximab Monoclonal Antibody
Other Names:
Drug: Obinutuzumab Monoclonal Antibody
Other Name: Gazyva
Drug: Cyclophosphamide Lympho-conditioning agent
Drug: Fludarabine Lympho-conditioning agent
Drug: IL-2 Biologic response modifier
|
Outcome Measures
Primary Outcome Measures :
- The incidence of subjects with Dose Limiting Toxicities within each dose level cohort. [ Time Frame: Day 29 ]
Secondary Outcome Measures :
- Incidence and nature of AEs of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma. [ Time Frame: Up to 5 years ]
- Severity of AEs of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma. [ Time Frame: Up to 5 years ]
- Objective response rate (ORR) of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma. [ Time Frame: Cycle 2 Day 29 ]
- FT516 pharmacokinetic data [ Time Frame: Cycle 1 and Cycle 2 Study Days: 1, 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
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
KEY INCLUSION CRITERIA:
Diagnosis of the following:
Regimen A (FT516 monotherapy):
- Primary Refractory AML
- Relapsed AML defined as not in CR after 1 or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required
Regimen B (FT516 + rituximab or obinutuzumab):
- Histologically documented B-cell lymphoma expected to express CD20 who have relapsed after or failed to respond to at least on prior treatment regimen and for whom there is no available therapy expected to improve survival.
All subjects:
- Provision of signed and dated informed consent form (ICF)
- Age ≥18 years old
- Stated willingness to comply with study procedures and duration
- Presence of measurable disease
- Provision of signed and dated ICF to agree to participate, at time of withdrawal or completion of this study, in Fate Therapeutics' long-term follow-up study.
KEY EXCLUSION CRITERIA:
All subjects:
- Females of reproductive potential who are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
- Evidence of insufficient organ function
- Receipt of therapy within 2 weeks prior to Cycle 1 Day 1 or within five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Cycle 1 Day 1
- Currently receiving or likely to require systemic immunosuppressive therapy
- Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Cycle 1 Day 1, or ongoing requirement for systemic graft-versus-host therapy
- Receipt of an allograft organ transplant
- Known active central nervous system (CNS) involvement by malignancy.
- Clinically significant cardiovascular disease
- Clinically significant infections including:
- 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 human albumin and DMSO
- QTc >450 msec on screening ECG
Additional Exclusion Criteria for Regimen A (FT516 monotherapy): Diagnosis of promyelocytic leukemia with t(15:17) translocation
Contacts and Locations
Contacts
| Contact: Kelly Griffis | 8588751800 | clinical@fatetherapeutics.com | |
| Contact: Jamuna Thimmarayappa | 8588751800 |
Locations
| United States, Arizona | |
| Mayo Clinic | Recruiting |
| Phoenix, Arizona, United States, 85054 | |
| United States, California | |
| UC San Diego | Recruiting |
| San Diego, California, United States, 92037 | |
| United States, Minnesota | |
| University of Minnesota Masonic Cancer Center | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Swedish Cancer Institute | Recruiting |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
Fate Therapeutics
Investigators
| Study Director: | Rebecca Elstrom, MD | Fate Therapeutics |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 9, 2019 | ||||||||
| First Posted Date ICMJE | July 17, 2019 | ||||||||
| Last Update Posted Date | March 5, 2021 | ||||||||
| Actual Study Start Date ICMJE | October 4, 2019 | ||||||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort. [ Time Frame: Day 29 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | FT516 in Subjects With Advanced Hematologic Malignancies | ||||||||
| Official Title ICMJE | A Phase I Study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory B-Cell Lymphoma | ||||||||
| 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 will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
72 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | May 2026 | ||||||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
KEY INCLUSION CRITERIA: Diagnosis of the following: Regimen A (FT516 monotherapy):
Regimen B (FT516 + rituximab or obinutuzumab):
All subjects:
KEY EXCLUSION CRITERIA: All subjects:
Additional Exclusion Criteria for Regimen A (FT516 monotherapy): Diagnosis of promyelocytic leukemia with t(15:17) translocation |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04023071 | ||||||||
| Other Study ID Numbers ICMJE | FT516-101 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Fate Therapeutics | ||||||||
| Study Sponsor ICMJE | Fate Therapeutics | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Fate Therapeutics | ||||||||
| Verification Date | March 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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