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Monoclonal Antibodies
FT576 for Multiple Myeloma
Phase 1
Recruiting
Research Sponsored by Fate Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of r/r MM with measurable disease by at least one of the following: Serum M-protein ≥1.0 g/dL, Urine M-protein ≥200 mg/24 hours, Involved serum free light chain level ≥10 mg/dL, with an abnormal kappa-lambda ratio if the serum M-protein <1.0 g/dL and/or urine M-protein <200 mg/24 hours
Regimens A and A1: MM relapsed or progressed after ≥3 prior approved therapies, including an IMiD, proteasome inhibitor, and anti-CD38 mAb
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline tumor assessment up to approximately 2 years after last dose of ft576
Awards & highlights
Study Summary
This trial is testing a new drug, FT576, for multiple myeloma (MM). The study will have two parts: a dose-escalation stage, where patients receive different doses of FT576 to find the best one, and an expansion stage, where patients receive FT576 in combination with daratumumab.
Who is the study for?
This trial is for adults with relapsed or refractory Multiple Myeloma who have tried at least two or three prior therapies, depending on the regimen. They should not be severely ill (ECOG PS <2), have significant infections like HIV/HBV/HCV, recent live vaccines, organ transplants, other cancers within 2 years (with exceptions), and must meet certain blood and organ function criteria.Check my eligibility
What is being tested?
The study tests FT576 alone and with daratumumab in different doses to find the safest and most effective amount for treating Multiple Myeloma. It's a Phase I trial that starts by increasing doses (dose-escalation) then gives it to more people at the best dose found (expansion stage).See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever, fatigue, nausea; blood cell count changes leading to increased infection risk; potential damage to organs where cancer cells are present due to targeted cell destruction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have relapsed or refractory multiple myeloma with measurable indicators.
Select...
My multiple myeloma has worsened after 3 treatments including IMiD, proteasome inhibitor, and anti-CD38.
Select...
My multiple myeloma worsened after at least 2 treatments, including an IMiD and a proteasome inhibitor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline tumor assessment up to approximately 2 years after last dose of ft576
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline tumor assessment up to approximately 2 years after last dose of ft576
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the RP2D which will be based on the overall safety and anti-tumor activity among the dose escalation and dose expansion cohorts
Incidence and nature of DLTs within each dose-escalation cohort to determine the MTD or MAD
Incidence, nature, and severity of adverse events
Secondary outcome measures
Duration of response (DOR)
Objective response rate (ORR)
Overall survival (OS)
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Regimen B1Experimental Treatment5 Interventions
FT576 multiple dose in combination with daratumumab in subjects with r/r MM
Group II: Regimen BExperimental Treatment5 Interventions
FT576 single dose in combination with daratumumab in subjects with r/r MM
Group III: Regimen A1Experimental Treatment4 Interventions
FT576 multiple dose monotherapy in subjects with r/r MM
Group IV: Regimen AExperimental Treatment4 Interventions
FT576 single dose monotherapy in subjects with r/r MM
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Daratumumab
2014
Completed Phase 3
~1860
Bendamustine
2015
Completed Phase 3
~2950
Find a Location
Who is running the clinical trial?
Fate TherapeuticsLead Sponsor
21 Previous Clinical Trials
1,633 Total Patients Enrolled
1 Trials studying Multiple Myeloma
42 Patients Enrolled for Multiple Myeloma
Ted Shih, PharmDStudy DirectorFate Therapeutics, Inc
2 Previous Clinical Trials
179 Total Patients Enrolled
1 Trials studying Multiple Myeloma
13 Patients Enrolled for Multiple Myeloma
John Byon, MD, PhDStudy DirectorFate Therapeutics, Inc
1 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your white blood cell count is too low without growth factor support, or your platelet count is too low without a recent platelet transfusion.I haven't had any cancer other than my current one in the last 2 years.I haven't had certain cancer treatments recently before starting the FT576 trial.I do not have significant infections like HIV, HBV, HCV, and haven't had a live vaccine or organ transplant recently.I have not had a heart attack in the last 6 months, my heart condition is stable, and my heart's pumping ability is sufficient.I haven't had a stroke, epilepsy, or similar brain conditions, nor taken medication for them in the last 2 years.I have previously received BCMA CAR T-cell therapy or BCMA-targeted treatments.I had brain or spinal cord cancer, treated successfully over 3 months ago with no current signs.I am not on or expected to need strong immune system suppressing drugs, except for corticosteroids.I have relapsed or refractory multiple myeloma with measurable indicators.Your kidneys, liver, or lungs are not working well, or you have high levels of certain substances in your blood, unless it's due to a specific condition called Gilbert's syndrome or your underlying cancer.My multiple myeloma has worsened after 3 treatments including IMiD, proteasome inhibitor, and anti-CD38.My daily activity is limited due to my health condition.My multiple myeloma worsened after at least 2 treatments, including an IMiD and a proteasome inhibitor.
Research Study Groups:
This trial has the following groups:- Group 1: Regimen A
- Group 2: Regimen A1
- Group 3: Regimen B
- Group 4: Regimen B1
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.
What potential risks have been associated with FT576 use?
"Due to the limited amount of clinical data available, FT576 was scored a 1 in terms of safety—as it is currently undergoing Phase 1 testing."
Answered by AI
How many participants are currently engaged in the experiment?
"To successfully complete this trial, 168 eligible subjects must be recruited. These participants can seek treatment at Oncology Hematology Care in Cincinnati or Medical Oncology Hematology Consultants in Newark."
Answered by AI
Is there still an opportunity to partake in the experiment?
"Affirmative. Information on clinicaltrials.gov suggests that this medical trial, which was initially posted on November 24th 2021, is currently searching for participants. A total of 168 patients need to be enrolled from 10 different healthcare centres."
Answered by AI
What are the ambitions of this experiment?
"As stated by the study's supporter, Fate Therapeutics, the primary goal of this project is to identify and quantify potential adverse effects. Alongside this primary outcome measure, other secondary objectives include determining relapse-free survival from complete response (CR), examining pharmacokinetics following FT576 administration, and measuring progression-free survival."
Answered by AI
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