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CAR T-cell Therapy

FT819 for Blood Cancer

Phase 1
Recruiting
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 CLL per iwCLL guidelines
- Relapsed/refractory disease following at least two prior systemic treatment regimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years after last dose of ft819
Awards & highlights

Study Summary

This trial is testing a new drug, FT819, as a possible treatment for various types of blood cancers. The study will have two parts: a dose-escalation stage, to find the best dose of the drug, and an expansion stage, to test the drug in more people.

Who is the study for?
Adults over 18 with certain B-cell blood cancers (like lymphoma, chronic leukemia, or acute leukemia) that have come back or didn't respond to at least two previous treatments can join. They must be able to consent and follow the study plan, and use birth control as required.Check my eligibility
What is being tested?
The trial is testing FT819 alone or with IL-2 in patients whose B-cell malignancies have relapsed or are resistant to treatment. It's a Phase I study where they'll first find the right dose and then see how well it works in specific groups of patients.See study design
What are the potential side effects?
Possible side effects may include reactions related to immune system activation, such as fever and fatigue; organ inflammation; infusion-related reactions; bone marrow suppression leading to low blood cell counts; and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with chronic lymphocytic leukemia.
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My condition did not improve after two different treatments.
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I am 18 years old or older.
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My cancer returned or didn't respond after 2+ standard treatments. If my cancer is Ph+, I also couldn't tolerate or didn't respond to a specific drug therapy.
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I have been diagnosed with B-ALL through specific tests.
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I have been diagnosed with a type of B-cell blood cancer.
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My lymphoma is confirmed to express CD19.
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My condition did not improve after 2 different cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years after last dose of ft819
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years after last dose of ft819 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 and nature of dose-limiting toxicities within each dose level cohort
Incidence, nature, and severity of adverse events (AEs) of FT819 as monotherapy and in combination with IL-2 in r/r B-cell lymphoma, r/r chronic lymphocytic leukemia, and r/r precursor B-cell acute lymphoblastic leukemia
Secondary outcome measures
Determination of the pharmacokinetics of FT819 cells in peripheral blood.
For B-ALL Only: Investigator-assessed relapse-free survival (RFS)
For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)
+4 more

Trial Design

12Treatment groups
Experimental Treatment
Group I: FT819 Step Fractionated Monotherapy, CLLExperimental Treatment4 Interventions
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
Group II: FT819 Step Fractionated Monotherapy, B-Cell LymphomaExperimental Treatment4 Interventions
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
Group III: FT819 Step Fractionated Monotherapy, B-ALLExperimental Treatment4 Interventions
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
Group IV: FT819 Step Fractionated Monotherapy in Combination with IL-2, CLLExperimental Treatment5 Interventions
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
Group V: FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell LymphomaExperimental Treatment5 Interventions
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
Group VI: FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALLExperimental Treatment5 Interventions
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
Group VII: FT819 Single-Dose in Combination with IL-2, CLLExperimental Treatment5 Interventions
FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
Group VIII: FT819 Single-Dose in Combination with IL-2, B-Cell LymphomaExperimental Treatment5 Interventions
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
Group IX: FT819 Single-Dose in Combination with IL-2, B-ALLExperimental Treatment5 Interventions
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
Group X: FT819 Single-Dose Monotherapy, CLLExperimental Treatment4 Interventions
FT819 single-dose monotherapy in adult subjects with r/r CLL
Group XI: FT819 Single-Dose Monotherapy, B-Cell LymphomaExperimental Treatment4 Interventions
FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
Group XII: FT819 Single-Dose Monotherapy, B-ALLExperimental Treatment4 Interventions
FT819 single-dose monotherapy in adult subjects with r/r B-ALL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine
2015
Completed Phase 3
~2950
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1080
IL-2
2007
Completed Phase 4
~1180

Find a Location

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor
21 Previous Clinical Trials
1,405 Total Patients Enrolled
Clinical DevelopmentStudy DirectorFate Therapeutics
35 Previous Clinical Trials
88,519 Total Patients Enrolled
Rebecca Elstrom, MDStudy DirectorFate Therapeutics
7 Previous Clinical Trials
698 Total Patients Enrolled

Media Library

FT819 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04629729 — Phase 1
B-Cell Lymphoma Research Study Groups: FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL, FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma, FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL, FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma, FT819 Step Fractionated Monotherapy, B-Cell Lymphoma, FT819 Single-Dose Monotherapy, CLL, FT819 Single-Dose in Combination with IL-2, CLL, FT819 Step Fractionated Monotherapy, CLL, FT819 Single-Dose Monotherapy, B-ALL, FT819 Single-Dose in Combination with IL-2, B-ALL, FT819 Step Fractionated Monotherapy, B-ALL, FT819 Single-Dose Monotherapy, B-Cell Lymphoma
B-Cell Lymphoma Clinical Trial 2023: FT819 Highlights & Side Effects. Trial Name: NCT04629729 — Phase 1
FT819 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04629729 — Phase 1

Frequently Asked Questions

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

What is the patient participation rate in this particular clinical experiment?

"Affirmative. The clinical trial, first posted on July 26th 2021, is actively recruiting according to data hosted on clinicaltrials.gov. There are 8 different sites that need to recruit a total of 297 patients for the study."

Answered by AI

How many places can individuals access this research initiative?

"At present, there are 8 sites servicing this medical trial. These locations span from Westwood to Madison and Birmingham as well as several other locales. To minimize travel difficulties when enrolling, it is prudent to select the closest site available."

Answered by AI

Are there currently opportunities for individuals to join this research endeavor?

"Affirmative. The clinical trial registry indicates that this medical investigation, which was first made public on July 26th 2021, is presently recruiting participants. There needs to be 297 individuals recruited from 8 distinct study locations."

Answered by AI

What additional investigations have been conducted on the usage of FT819?

"FT819's first clinical trial was conducted at the City of Hope Comprehensive Cancer Centre in 1997. Since then, 1326 trials have been concluded and 901 active recruitments are being held across the United States, primarily centered around Westwood, Kansas."

Answered by AI

What ailment is FT819 the most commonly prescribed for?

"FT819 has been approved to treat multiple sclerosis, as well as acute myelocytic leukemia and retinoblastoma. Additionally, it is useful for treating histiocytic lymphomas."

Answered by AI

Has the FDA given its endorsement to FT819?

"The safety of FT819 was evaluated at a 1 on our scale due to this being an early-stage trial, meaning there is only limited evidence available regarding its effectiveness and security."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FT819 in Subjects With B-cell Malignancies
2021. "FT819 in Subjects With B-cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04629729.
~42 spots leftby Sep 2024
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