FT819 for Blood Cancer

Recruiting at 17 trial locations

Overseen By Fate Trial Disclosure

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Fate Therapeutics

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, CNS disease, Cardiovascular, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

54 Participants Needed

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot have received any therapy within 2 weeks before starting the trial. You also cannot be on systemic immunosuppressive therapy or require it during the trial.

Research Team

Fate Trial Disclosure

Principal Investigator

Fate Therapeutics

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 B-Cell Lymphoma.

I have been diagnosed with chronic lymphocytic leukemia.

My condition did not improve after two different treatments.

Exclusion Criteria

I do not have non-cancerous brain conditions like stroke or epilepsy.

I haven't taken any cancer therapy or investigational drugs recently.

- Positive serologic test results for HIV infection

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Participants receive FT819 as monotherapy and in combination with IL-2 in a dose-escalation stage

4 weeks

Multiple visits as per dosing schedule

Expansion

Participants are enrolled into indication-specific cohorts for further treatment

4-8 weeks

Multiple visits as per cohort schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29

Treatment Details

Interventions

• FT819

Trial Overview 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.

Participant Groups

Group I: FT819 Step Fractionated Monotherapy, CLL Experimental Treatment 4 Interventions

FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL

Group II: FT819 Step Fractionated Monotherapy, B-Cell Lymphoma Experimental Treatment 4 Interventions

FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma

Group III: FT819 Step Fractionated Monotherapy, B-ALL Experimental Treatment 4 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, CLL Experimental Treatment 5 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 Lymphoma Experimental Treatment 5 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-ALL Experimental Treatment 5 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, CLL Experimental Treatment 5 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 Lymphoma Experimental Treatment 5 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-ALL Experimental Treatment 5 Interventions

FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL

Group X: FT819 Single-Dose Monotherapy, CLL Experimental Treatment 4 Interventions

FT819 single-dose monotherapy in adult subjects with r/r CLL

Group XI: FT819 Single-Dose Monotherapy, B-Cell Lymphoma Experimental Treatment 4 Interventions

FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma

Group XII: FT819 Single-Dose Monotherapy, B-ALL Experimental Treatment 4 Interventions

FT819 single-dose monotherapy in adult subjects with r/r B-ALL

Who Is Running the Clinical Trial?

Fate Therapeutics

Lead Sponsor

Trials

22

Recruited

1,200+