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CAR T-cell Therapy
FT538 for Multiple Myeloma
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
Approved for 20 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing FT538, a new cancer treatment, on patients with acute myeloid leukemia and multiple myeloma. Researchers want to find the best dose and see how well it works alone or with other drugs.
Eligible Conditions
- Multiple Myeloma
- Acute Myeloid Leukemia
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
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
+5 moreSide effects data
From 2024 Phase 1 trial • 9 Patients • NCT04714372100%
Fatigue
100%
Generalized edema
100%
Anemia
100%
Aspartate aminotransferase increased
100%
Neutrophil count decreased
100%
Hypoalbuminemia
100%
Generalized muscle weakness
100%
Constipation
100%
Diarrhea
100%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
100%
Pulmonary edema
100%
Other, specify - Disease progression
100%
Febrile neutropenia
100%
Sinus tachycardia
100%
Hearing impaired
100%
Lymphocyte count decreased
100%
Platelet count decreased
100%
White blood cell decreased
100%
Anorexia
100%
Hypokalemia
100%
Hypophosphatemia
100%
Pain in extremity
100%
Encephalopathy
100%
Epistaxis
100%
Hypoxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
Awards & Highlights
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.
Trial 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 4
~1860
Daratumumab
2014
Completed Phase 3
~2000
Elotuzumab
2016
Completed Phase 3
~910
FT538
2021
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
Fate TherapeuticsLead Sponsor
21 Previous Clinical Trials
1,156 Total Patients Enrolled
1 Trials studying Multiple Myeloma
31 Patients Enrolled for Multiple Myeloma
John Byon, MDStudy DirectorFate Therapeutics, Inc
Fate Trial DisclosureStudy DirectorFate Therapeutics, Inc
10 Previous Clinical Trials
345 Total Patients Enrolled
1 Trials studying Multiple Myeloma
31 Patients Enrolled for Multiple Myeloma
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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