FT516 for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Research Sponsored by Fate Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing FT516, a special cell-based treatment, in patients with AML and B-cell lymphoma. The treatment uses engineered cells to find and destroy cancer cells, and works even better when combined with another medicine that boosts the immune system.

Eligible Conditions

Lymphoma
Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

FT516 pharmacokinetic data

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing ScheduleExperimental Treatment6 Interventions

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.

Group II: FT516 in Combination with Monoclonal Antibodies following Bendamustine ConditioningExperimental Treatment5 Interventions

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.

Group III: FT516 in Combination with Monoclonal AntibodiesExperimental Treatment6 Interventions

FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.

Group IV: FT516 MonotherapyExperimental Treatment4 Interventions

FT516 monotherapy in adult subjects with r/r AML.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FT516

2020

Completed Phase 1

~10