CAR T-cell Therapy

FT516 for Non-Hodgkin's Lymphoma

University of Minnesota Masonic Cancer Center, Minneapolis, MN
Targeting 2 different conditionsFT516 +6 morePhase 1Waitlist AvailableResearch Sponsored by Fate Therapeutics

Study Summary

This trial is testing a new cancer drug, FT516, to see if it is safe and effective when used alone or with other drugs to treat AML or B-cell lymphoma.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Acute Myeloid Leukemia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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To provide accurate summaries, I would need the specific diagnoses mentioned in the criterion. Could you please provide the diagnoses?
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You have a type of blood cancer called acute myeloid leukemia (AML) that has come back after treatment attempts. If you are over 60 years old, you do not need to have previous re-treatment attempts.
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You have a certain type of lymphoma that hasn't responded to previous treatments and there are no other treatments available that can help improve your survival.
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You will be receiving only one type of treatment called Regimen A (FT516).
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You are receiving a treatment called Regimen B, which includes FT516 and either rituximab or obinutuzumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence, nature, and severity of AEs, of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.
Secondary outcome measures
FT516 pharmacokinetic data
Investigator-assessed anti-tumor activity of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.

Awards & Highlights

Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
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: FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing ScheduleExperimental Treatment6 Interventions
FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
Group II: FT516 in Combination with Monoclonal Antibodies following Bendamustine ConditioningExperimental Treatment5 Interventions
Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
Group III: FT516 in Combination with Monoclonal AntibodiesExperimental Treatment6 Interventions
FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
Group IV: FT516 MonotherapyExperimental Treatment4 Interventions
FT516 monotherapy in adult subjects with r/r AML.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Cyclophosphamide
FDA approved
Fludarabine
FDA approved
IL-2
2007
Completed Phase 4
~1180
FT516
Not yet FDA approved
Bendamustine
2015
Completed Phase 3
~2950
Obinutuzumab
FDA approved

Find a site

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor
19 Previous Clinical Trials
1,346 Total Patients Enrolled
Rebecca Elstrom, MDStudy Director
Fate Therapeutics
7 Previous Clinical Trials
1,012 Total Patients Enrolled
Fate Trial DisclosureStudy Director
Fate Therapeutics
10 Previous Clinical Trials
794 Total Patients Enrolled

Media Library

FT516 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04023071 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning, FT516 in Combination with Monoclonal Antibodies, FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule, FT516 Monotherapy
Non-Hodgkin's Lymphoma Clinical Trial 2023: FT516 Highlights & Side Effects. Trial Name: NCT04023071 — Phase 1
FT516 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04023071 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the patient population engaged in this medical study?

"Indeed, the trial is still recruiting. According to clinicaltrials.gov, it was originally posted on October 4th 2019 and most recently updated on July 25th 2022. Currently 234 volunteers are needed across 7 different locations for this study."

Answered by AI

Has the FDA sanctioned FT516 for use yet?

"The safety of FT516 has been given a rating of 1, owing to the limited amount of clinical data available regarding its efficacy and potential side effects. This is an early phase trial."

Answered by AI

What are the known outcomes of prior FT516 studies?

"As of now, 1241 FT516 studies are ongoing with 238 in Phase 3. Most these trials take place in Philadelphia; however, there exist 41188 other sites conducting clinical research on this drug."

Answered by AI

What medical purpose is FT516 typically employed for?

"FT516 is the most effective way to treat lung cancer and can be utilized to manage numerous other ailments like multiple sclerosis, b-cell lymphomas, and polyangium."

Answered by AI

Is enrollment still open for participation in this research project?

"Indeed, according to the data accessible on clinicaltrials.gov this experiment is at present open for enrollment. Originally posted in October 4th 2019, it was recently refreshed on July 25th 2022. Approximately 234 volunteers must be recruited from 7 distinct sites."

Answered by AI

How many healthcare locations are currently conducting this experiment in the state?

"Seven different clinical centres are taking part in this trial, with Seattle's Swedish Cancer Institute, Phoenix's Mayo Clinic, and Dallas' UT Southwestern being some of the leading sites. Additionally, four other locations have been recruited to take part."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FT516 in Subjects With Advanced Hematologic Malignancies
2019. "FT516 in Subjects With Advanced Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04023071.
~9 spots leftby May 2024
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