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CAR T-cell Therapy

FT516 for Non-Hodgkin's Lymphoma

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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

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.

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
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100
IL-2
2007
Completed Phase 4
~1180
FT516
2020
Completed Phase 1
~10
Bendamustine
2015
Completed Phase 3
~2950
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor
21 Previous Clinical Trials
1,729 Total Patients Enrolled
Rebecca Elstrom, MDStudy DirectorFate Therapeutics
7 Previous Clinical Trials
1,022 Total Patients Enrolled
Fate Trial DisclosureStudy DirectorFate 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
~13 spots leftby Apr 2025