Trials / Terminated
TerminatedNCT04023071
FT516 in Subjects With Advanced Hematologic Malignancies
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Fate Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FT516 | Experimental Interventional Therapy |
| DRUG | Rituximab | Monoclonal Antibody |
| DRUG | Obinutuzumab | Monoclonal Antibody |
| DRUG | Cyclophosphamide | Conditioning agent |
| DRUG | Fludarabine | Conditioning agent |
| DRUG | IL-2 | Biologic response modifier |
| DRUG | Bendamustine | Conditioning agent |
Timeline
- Start date
- 2019-10-04
- Primary completion
- 2023-10-23
- Completion
- 2023-10-23
- First posted
- 2019-07-17
- Last updated
- 2023-10-26
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04023071. Inclusion in this directory is not an endorsement.