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Monoclonal Antibodies
FT538 + Daratumumab for Acute Myeloid Leukemia
Phase 1
Waitlist Available
Led By Joseph Maakaron, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 12 years or older at the time of consent - Please note, enrollment of minors will be begin until permission to proceed is received from the FDA. At that time, the protocol will be updated to open enrollment to minors
Weight ≥ 50 kg due to FT538 fixed cell dosing and FT538 product pre-dose packaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months from the 1st ft538 infusion
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see what the maximum safe dose is. It is for people with a certain kind of leukemia.
Who is the study for?
This trial is for people aged 12 and older with advanced acute myeloid leukemia (AML) or related diseases, weighing at least 50 kg. Participants must have a heart function of LVEF ≥ 40%, adequate organ function, and agree to use effective contraception. It excludes those with certain other medical conditions, recent treatments, active infections, cardiovascular disease requiring immunosuppression, or known allergies to study drugs.Check my eligibility
What is being tested?
The trial tests the combination of FT538 cells with Daratumumab in patients with AML. The goal is to find the highest dose that's safe (MTD). Patients will receive escalating doses of FT538 alongside standard doses of Daratumumab as well as Fludarabine and Cyclophosphamide pre-treatment.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever and fatigue; infusion-related reactions from Daratumumab; bone marrow suppression leading to low blood counts; nausea; potential liver enzyme elevation due to drug interactions; and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 years old or older.
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I weigh at least 50 kg.
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I am mostly active and can carry out daily activities without significant help.
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My kidney function is good, with a filtration rate of at least 50 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months from the 1st ft538 infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months from the 1st ft538 infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants experiencing Dose Limiting Toxicity (DLT) events
Secondary outcome measures
Number of participants achieving complete remission (CR + CRi)
Number of participants experiencing adverse events
Number of participants with Overall Survival (OS)
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Dose Level 4: FT538 at 1.5 x10^9 cells/doseExperimental Treatment4 Interventions
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Group II: Dose Level 3: FT538 at 1 x10^9 cells/doseExperimental Treatment4 Interventions
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Group III: Dose Level 2: FT538 at 3 x10^8 cells/doseExperimental Treatment4 Interventions
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Group IV: Dose Level 1: FT538 at 1 x10^8 cells/doseExperimental Treatment4 Interventions
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,614 Total Patients Enrolled
Joseph Maakaron, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
1 Previous Clinical Trials
37 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 12 years old or older.I have been diagnosed with acute promyelocytic leukemia.I weigh at least 50 kg.I am using effective birth control and will continue for 12 months after my last treatment.My cancer returned less than 3 months after my stem cell transplant.I am not pregnant or breastfeeding, and if capable of becoming pregnant, I have a recent negative pregnancy test.I am mostly active and can carry out daily activities without significant help.I have been treated for GvHD with systemic immunosuppression within the last 14 days.I have not received a live vaccine in the last 6 weeks.I have a serious infection that hasn't been treated or controlled.I am not on strong immune system-suppressing drugs during the trial period, except for inhaled or topical steroids.My organs are functioning well enough to start treatment.I am a male using effective birth control or am sterile, and my partner could become pregnant.I agree to sign up for a 15-year follow-up study.I have had a solid organ transplant.I have had a heart attack in the last 6 months or have serious heart issues.My kidney function is good, with a filtration rate of at least 50 mL/min.I have had brain involvement from my cancer but have been treated and stable for 2 months.My liver enzymes AST and ALT are within normal limits, not due to cancer.I haven't had cancer treatment except for symptom relief in the last 2 weeks or investigational therapy in the last 28 days.You must use contraception if you are a man or a woman.I haven't had epilepsy, CNS vasculitis, or neurodegenerative diseases, nor taken medication for them in the last 2 years.You are allergic to any of the study drugs or their ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1: FT538 at 1 x10^8 cells/dose
- Group 2: Dose Level 2: FT538 at 3 x10^8 cells/dose
- Group 3: Dose Level 3: FT538 at 1 x10^9 cells/dose
- Group 4: Dose Level 4: FT538 at 1.5 x10^9 cells/dose
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently being monitored in this research experiment?
"Affirmative. Data hosted on clinicaltrials.gov denotes that this research, which was initially posted on November 3rd 2021, is actively seeking patients to participate in the trial. The medical study requires 50 individuals at a single location."
Answered by AI
Has there been any precedent for the use of FT538 in medical research?
"At this moment, 1041 clinical trials are being conducted for FT538. Of these studies, 193 have progressed to Phase 3 of the trial process and 35143 sites across the world are hosting them. The majority of these experiments can be found in Philadelphia, Pennsylvania."
Answered by AI
In what capacity is FT538 most commonly utilized?
"FT538 is a widely-used medication for treating inflammatory breast cancer (ibc). Additionally, it can be employed to address multiple sclerosis, leukemia, myelocytic acute and cell transplants."
Answered by AI
What potential harm could FT538 pose to individuals?
"The safety rating of FT538 is a 1 due to the limited amount of evidence available from Phase 1 trials that suggest its efficacy and safety."
Answered by AI
Can new participants still enroll in this research endeavor?
"Clinicaltrials.gov reveals that this medical investigation was first posted on November 3rd 2021 and is actively seeking participants. The last update to the trial information was made on August 26th 2022."
Answered by AI
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