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CAR T-cell Therapy
FT516 in Subjects With Advanced Hematologic Malignancies
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.
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
Obinutuzumab
2014
Completed Phase 3
~3470
Bendamustine
2015
Completed Phase 3
~3230
IL-2
2007
Completed Phase 4
~1100
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860
Rituximab
1999
Completed Phase 4
~2990
Find a Location
Who is running the clinical trial?
Fate TherapeuticsLead Sponsor
21 Previous Clinical Trials
1,126 Total Patients Enrolled
Rebecca Elstrom, MDStudy DirectorFate Therapeutics
7 Previous Clinical Trials
680 Total Patients Enrolled
Fate Trial DisclosureStudy DirectorFate Therapeutics
10 Previous Clinical Trials
315 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a certain type of lymphoma that hasn't responded to previous treatments and there are no other treatments available that can help improve your survival.You are allergic to human albumin or DMSO.You have a type of blood cancer called acute myeloid leukemia (AML) that has come back after treatment attempts. If you are over 60 years old, you do not need to have previous re-treatment attempts.You have a serious heart condition that could affect your participation in the study.To provide accurate summaries, I would need the specific diagnoses mentioned in the criterion. Could you please provide the diagnoses?You will be receiving only one type of treatment called Regimen A (FT516).You are receiving a treatment called Regimen B, which includes FT516 and either rituximab or obinutuzumab.
Research Study Groups:
This trial has the following groups:- Group 1: FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning
- Group 2: FT516 in Combination with Monoclonal Antibodies
- Group 3: FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
- Group 4: FT516 Monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.