FT819 for Blood Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Fate Therapeutics
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called FT819, alone or with IL-2, in patients with certain blood cancers that have not responded to other treatments. FT819 targets cancer cells, and IL-2 boosts the immune system.
Eligibility Criteria
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.Inclusion Criteria
I have been diagnosed with chronic lymphocytic leukemia.
My condition did not improve after two different treatments.
I am 18 years old or older.
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.
I have been diagnosed with B-ALL through specific tests.
I have been diagnosed with a type of B-cell blood cancer.
My lymphoma is confirmed to express CD19.
My condition did not improve after 2 different cancer treatments.
Exclusion Criteria
I do not have non-cancerous brain conditions like stroke or epilepsy.
I have received an organ transplant from another person.
I am currently on or might need drugs that weaken my immune system.
I have tested positive for Hepatitis B.
I have a serious heart condition.
My body weight is less than 50 kg.
I need continuous treatment for GvHD after a stem cell or CAR-T transplant.
My cancer has spread to my brain or spinal cord.
I am not pregnant or breastfeeding.
My daily activity is limited due to my health condition.
Treatment Details
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.
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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mayo FloridaJacksonville, FL
UCLA Ronald Reagan Medical CenterLos Angeles, CA
Mayo ArizonaPhoenix, AZ
Scripps Green HospitalLa Jolla, CA
More Trial Locations
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Who is running the clinical trial?
Fate TherapeuticsLead Sponsor