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Monoclonal Antibodies

FT576 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
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
Must not have
Evidence of insufficient organ function: CrCL <50 ml/min by Cockcroft-Gault or other institutional method, T bilirubin >1.5x ULN, except for Gilbert's syndrome, AST >3x ULN or ALT >3x ULN, unless directly due to underlying malignancy, O2 sat <92% on room air
Clinically significant infections, including: HIV positive by serology, HBV positive by serology or PCR, HCV positive by serology or PCR, Live vaccine <6 weeks prior to start of conditioning, Receipt of an allograft organ transplant, Ongoing requirement for systemic graft-versus-host disease therapy, Plasma cell leukemia defined as a plasma cell count >2000/mm^3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline tumor assessment up to approximately 2 years after last dose of ft576
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment called FT576 alone and with an existing drug, daratumumab, in patients with multiple myeloma. Multiple myeloma is a cancer of plasma cells in the bone marrow. FT576 aims to kill cancer cells directly, while daratumumab helps the immune system to destroy these cells. Daratumumab has shown effectiveness in treating multiple myeloma, both alone and in combination with other drugs.

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.
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).
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 below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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.
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I do not have significant infections like HIV, HBV, HCV, and haven't had a live vaccine or organ transplant recently.
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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.
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I haven't had a stroke, epilepsy, or similar brain conditions, nor taken medication for them in the last 2 years.
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I am not on or expected to need strong immune system suppressing drugs, except for corticosteroids.
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My daily activity is limited due to my health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline tumor assessment up to approximately 2 years after last dose of ft576
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline tumor assessment up to approximately 2 years after last dose of ft576 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Duration of response (DOR)
Objective response rate (ORR)
Overall survival (OS)
+3 more

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: Regimens B-B4Experimental Treatment5 Interventions
FT576 single dose in combination with daratumumab in subjects with r/r MM
Group II: Regimens A-A4Experimental Treatment4 Interventions
FT576 single dose monotherapy in subjects with r/r MM
Group III: Regimen B1Experimental Treatment5 Interventions
FT576 multiple dose in combination with daratumumab in subjects with r/r MM
Group IV: Regimen A1Experimental Treatment4 Interventions
FT576 multiple dose monotherapy in subjects with r/r MM
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2320
Fludarabine
2012
Completed Phase 4
~1860
Daratumumab
2014
Completed Phase 3
~2000
Bendamustine
2015
Completed Phase 3
~3230

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Multiple Myeloma treatments target the disease through various mechanisms. Daratumumab, a CD38 monoclonal antibody, binds to the CD38 protein on myeloma cells, leading to cell death through immune-mediated mechanisms such as complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity. FT576, an investigational therapy, is designed to enhance the immune system's ability to target and destroy myeloma cells, potentially through engineered immune cells. Proteasome inhibitors like bortezomib disrupt protein degradation in myeloma cells, causing cell death, while immunomodulatory drugs like lenalidomide enhance the immune response against myeloma cells and inhibit their growth. These mechanisms are crucial for Multiple Myeloma patients as they offer targeted approaches to control and potentially eradicate the disease, improving survival and quality of life.
Novel treatment approaches for patients with relapsed and refractory multiple myeloma.

Find a Location

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor
21 Previous Clinical Trials
1,167 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
129 Total Patients Enrolled

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05182073 — Phase 1
Multiple Myeloma Research Study Groups: Regimens A-A4, Regimens B-B4, Regimen A1, Regimen B1
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT05182073 — Phase 1
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05182073 — Phase 1
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