Neoplasms

Blood and Lymph Conditions

All Conditions

Heart and Blood Diseases

Immune System Diseases

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Neoplasms by Histologic Type

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Daratumumab

Immunoglobulins

Elotuzumab

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

FT538 monotherapy in subjects with r/r AML

FT538 in combination with daratumumab in subjects with r/r MM

FT538 in combination with elotuzumab in subjects with r/r MM

Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell

FT538

Fate Trial Disclosure

This is a Phase I dose-finding study of FT538 as monotherapy in acute myeloid leukemia (AML) and in combination with monoclonal antibodies in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

FT538 in Subjects With Advanced Hematologic Malignancies

A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma

Proportion of subjects who achieve a CR, CRMRD-, CRi, MLFS, or PR, as determined by the investigator according to 2017 ELN criteria for AML, and the proportion of subjects with a best overall response of sCR, CR, VGPR, or PR, as determined by the investigator according to standard IMWG for MM response criteria

Defined as the duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death due to progressive disease, as determined by the investigator according to standard IMWG response criteria

Defined as the time from first dose of study treatment to disease progression or relapse, or to the day of death from any cause, as determined by the investigator according to standard IMWG response criteria

Defined as the time from initial CR (including CRMRD-, CR, and CRi) to hematologic relapse or death due to any cause, as determined by the investigator according to 2017 ELN criteria for AML, and defined as the duration from the start of sCR or CR until the time of relapse from sCR or CR, as determined by the investigator according to standard IMWG response criteria for MM

defined as the time from first dose of lympho-conditioning to the date of PD, or relapse from CR or CRi, or death from any cause, according to 2017 ELN criteria

defined as the time from first dose of lympho-conditioning to death from any cause

defined as the time from first dose of lympho-conditioning to best response

The PK of FT538 in peripheral blood will be reported as the relative percentage of product (FT538) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
FT538 in Subjects With Advanced Hematologic Malignancies	NCT04614636	Acute Myeloid L... AML, Adult Multiple Myelom... Myeloma	FT538 Cyclophosphamid... Fludarabine Daratumumab Elotuzumab	18 Years -	Fate Therapeutics
FT538 in Subjects With Advanced Hematologic Malignancies	NCT04614636	Acute Myeloid L... AML, Adult Multiple Myelom... Myeloma	FT538 Cyclophosphamid... Fludarabine Daratumumab Elotuzumab	18 Years -	Fate Therapeutics

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