What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as those involving Daratumumab, often lead to side effects like neutropenia, upper respiratory tract infections, and pneumonia. Daratumumab combinations, such as with bortezomib, lenalidomide, and dexamethasone, can also cause severe lymphocytopenia, increasing the risk of infections like Epstein-Barr virus or CMV reactivation and fungal meningitis. Other frequent side effects include fatigue, diarrhea, hypertension, and infusion-related reactions. These treatments may also result in anemia, thrombocytopenia, and gastrointestinal issues like nausea and constipation.

What prior FDA approvals exist?

Daratumumab, a CD38 monoclonal antibody, has been FDA-approved for the treatment of multiple myeloma in various combinations, including with bortezomib, lenalidomide, and dexamethasone. Other similar FDA-approved treatments include elotuzumab, another monoclonal antibody, used in combination with lenalidomide and dexamethasone. Additionally, carfilzomib, a proteasome inhibitor, has been approved in combination with daratumumab and dexamethasone. These approvals highlight the trend of using monoclonal antibodies and combination regimens to enhance treatment efficacy in multiple myeloma.

What other types of research exist?

Promising novel alternatives for multiple myeloma treatment in 2024 include: <ol> <li>Bispecific T-cell engagers (BiTEs) such as teclistamab, which targets BCMA and CD3.</li> <li></li> </ol> CAR T-cell therapies like idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), which target BCMA. 3. Antibody-drug conjugates (ADCs) such as belantamab mafodotin, which targets BCMA. 4. Next-generation proteasome inhibitors like oprozomib. 5. Selective inhibitors of nuclear export (SINE) such as selinexor.

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Monoclonal Antibodies

FT576 for Multiple Myeloma

Q: What is the mechanism of action of this treatment?

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.

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:

Select...

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.

Select...

I do not have significant infections like HIV, HBV, HCV, and haven't had a live vaccine or organ transplant recently.

Select...

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.

Select...

I haven't had a stroke, epilepsy, or similar brain conditions, nor taken medication for them in the last 2 years.

Select...

I am not on or expected to need strong immune system suppressing drugs, except for corticosteroids.

Select...

My daily activity is limited due to my health condition.

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

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

~2310

Fludarabine

2012

Completed Phase 4

~1860

Daratumumab

2014

Completed Phase 3

~2000

Bendamustine

2015

Completed Phase 3

~3230

0 / 9Eligibility criteria met

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.