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CAR T-cell Therapy
FT538 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 from baseline tumor assessment up to approximately 2 years after last dose of ft538
Awards & highlights
Study Summary
This trial is testing a new cancer drug called FT538. The first part of the trial is to find the best dose of the drug. The second part is to see if the drug works better when used with other drugs that are already used to treat cancer.
Eligible Conditions
- Acute Myeloid Leukemia
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline tumor assessment up to approximately 2 years after last dose of ft538
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline tumor assessment up to approximately 2 years after last dose of ft538
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities (DLTs) within each dose level cohort
Nature of dose-limiting toxicities within each dose level cohort
Secondary outcome measures
Determination of the pharmacokinetics (PK) of FT538 cells in peripheral blood
Duration of response (DOR) of FT538 in combination with daratumumab or elotuzumab in r/r MM
Event-free survival (EFS) of FT538 as monotherapy in r/r AML
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: FT538 in Combination with ElotuzumabExperimental Treatment4 Interventions
FT538 in combination with elotuzumab in subjects with r/r MM
Group II: FT538 in Combination with DaratumumabExperimental Treatment4 Interventions
FT538 in combination with daratumumab in subjects with r/r MM
Group III: FT538 MonotherapyExperimental Treatment3 Interventions
FT538 monotherapy in subjects with r/r AML
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
2012
Completed Phase 3
~1080
Daratumumab
2014
Completed Phase 3
~1990
Elotuzumab
2016
Completed Phase 3
~800
Find a Location
Who is running the clinical trial?
Fate TherapeuticsLead Sponsor
21 Previous Clinical Trials
1,759 Total Patients Enrolled
John Byon, MDStudy DirectorFate Therapeutics, Inc
Fate Trial DisclosureStudy DirectorFate Therapeutics, Inc
10 Previous Clinical Trials
824 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to albumin (human) or DMSO.You have been diagnosed with one of the following conditions according to the treatment plan:This study is specifically for patients with relapsed or refractory acute myeloid leukemia (AML) who will be treated with the medication FT538 alone (Regimen A).You have cancer that has spread to your brain or spinal cord and is actively causing problems.You are being considered for Treatment Regimens B or C, which involve using a combination of drugs called FT538 and a type of medication called monoclonal antibodies for patients with relapsed or refractory multiple myeloma.For Regimen C, you have multiple myeloma that has come back or gotten worse after treatment with proteasome inhibitors and immunomodulatory therapy.Your organs are not functioning properly, as determined by the study guidelines.You have a serious heart condition that is defined by the study's rules.You have had a non-cancerous disease affecting your brain or nervous system, such as stroke, epilepsy, or neurodegenerative disease, or have taken medications for these conditions within the past 2 years.For regimen B, you must have multiple myeloma that has come back or gotten worse after trying at least two different treatments, including a drug that blocks proteasomes and a drug that helps regulate the immune system.
Research Study Groups:
This trial has the following groups:- Group 1: FT538 Monotherapy
- Group 2: FT538 in Combination with Daratumumab
- Group 3: FT538 in Combination with Elotuzumab
Awards:
This trial has 3 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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