FT516 in Subjects With Advanced Hematologic Malignancies

Phase 1 Terminated 72 enrolled Fate Therapeutics

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2019-10-04
Primary completion: 2023-10-23
Completion: 2023-10-23

Publications

Strati P, Castro J, Goodman A, Bachanova V, Kamdar M, Awan FT, Solomon SR, Wong L, Wong C, Patel D, Bickers C, Zhao W, Bashir Z, Valamehr B, Elstrom RL, Patel K. Off-the-shelf induced pluripotent stem-cell-derived natural killer-cell therapy in relapsed or refractory B-cell lymphoma: a multicentre, open-label, phase 1 study. Lancet Haematol. 2025 Jul;12(7):e505-e515. doi: 10.1016/S2352-3026(25)00142-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FT516	Cell therapy	3e+07 cells	Intravenous
Subject	FT516	Cell therapy	9e+08 cells	Intravenous
Subject	Obinutuzumab	Monoclonal antibody	1000 mg	—
Subject	Rituximab	Monoclonal antibody	375 mg/m2	—
Background	Bendamustine	Small molecule	90 mg/m2	—
Background	Cyclophosphamide	Other / unclassified	500 mg/m2	—
Background	Fludarabine	Small molecule	30 mg/m2	—
Background	aldesleukin	Protein / enzyme biologic	6e+06 iu	Subcutaneous

FT516 in Subjects With Advanced Hematologic Malignancies

Summary

Timeline

Publications

Drugs

Indications