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FT576 for Multiple Myeloma

City of Hope, Duarte, CA
Multiple Myeloma+1 More ConditionsFT576 - Drug
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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FT538

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: From baseline tumor assessment up to approximately 2 years after last dose of FT576

Day 40
Incidence and nature of DLTs within each dose-escalation cohort to determine the MTD or MAD
Incidence, nature, and severity of adverse events
Day 29
Pharmacokinetics (PK) of FT576
Day 29
Determine the RP2D which will be based on the overall safety and anti-tumor activity among the dose escalation and dose expansion cohorts
Year 2
Objective response rate (ORR)
Up to 15 years
Duration of response (DOR)
Overall survival (OS)
Progression-free survival (PFS)
Relapse-free survival (RFS) from complete response (CR)

Trial Safety

Phase-Based Safety

1 of 3

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1
Iberdomide, Elotuzumab and Dexamethasone
1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

Regimen A1
1 of 4
Regimen A
1 of 4
Regimen B1
1 of 4
Regimen B
1 of 4

Experimental Treatment

168 Total Participants · 4 Treatment Groups

Primary Treatment: FT576 · No Placebo Group · Phase 1

Regimen A1Experimental Group · 5 Interventions: Bendamustine, FT576 (Allogenic CAR NK cells with BCMA expression), FT576, Cyclophosphamide, Fludarabine · Intervention Types: Drug, Drug, Drug, Drug, Drug
Regimen AExperimental Group · 5 Interventions: Bendamustine, FT576 (Allogenic CAR NK cells with BCMA expression), FT576, Cyclophosphamide, Fludarabine · Intervention Types: Drug, Drug, Drug, Drug, Drug
Regimen B1Experimental Group · 6 Interventions: Daratumumab, Bendamustine, FT576 (Allogenic CAR NK cells with BCMA expression), FT576, Cyclophosphamide, Fludarabine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Regimen BExperimental Group · 6 Interventions: Daratumumab, Bendamustine, FT576 (Allogenic CAR NK cells with BCMA expression), FT576, Cyclophosphamide, Fludarabine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2016
Completed Phase 3
~1740
Bendamustine
2015
Completed Phase 3
~2950
Cyclophosphamide
1995
Completed Phase 3
~3920
Fludarabine
2012
Completed Phase 3
~1090

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline tumor assessment up to approximately 2 years after last dose of ft576

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor
17 Previous Clinical Trials
928 Total Patients Enrolled
1 Trials studying Multiple Myeloma
42 Patients Enrolled for Multiple Myeloma
Fate Trial DisclosureStudy DirectorFate Therapeutics, Inc
9 Previous Clinical Trials
698 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

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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