FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

Recruiting at3 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Fate Therapeutics

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing FT500, a ready-made treatment using special immune cells, in patients with advanced solid tumors. It helps the immune system fight cancer and can work even when other treatments fail.

Research Team

Fate Trial Disclosure

Principal Investigator

[e-mail]

Eligibility Criteria

Inclusion Criteria

1A. Regimen A: FT500 Monotherapy (Dose Escalation): An advanced solid tumor malignancy, including lymphoma, in a subject who has failed or refused available FDA-approved therapies and is now a candidate for salvage therapy.

1B. Regimen B and BB (Dose Escalation): FT500 (+ IL-2, Regimen BB only) + ICI: An advanced solid tumor malignancy, including lymphomas, that has progressed on treatment with at least one ICI (ie, nivolumab, pembrolizumab or atezolizumab), in a subject who has also failed or refused other available approved therapies and is now a candidate for salvage therapy.

1C. Regimen B(Dose Expansion): FT500 (+ IL-2, Regimen BB only) + ICI An advanced solid tumor malignancy or lymphoma in a subject with disease relapse or progression on an ICI (nivolumab, pembrolizumab, or atezolizumab) in an approved indication per the respective USPI.

Treatment Details

Interventions

• Atezolizumab (Checkpoint Inhibitor)
• FT500 (NK Cell Therapy)
• Nivolumab (Checkpoint Inhibitor)
• Pembrolizumab (Checkpoint Inhibitor)

Participant Groups

Group I: FT500 in Combination with Immune Checkpoint Inhibitor Experimental Treatment 6 Interventions

FT500 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.

Group II: FT500 Monotherapy Experimental Treatment 3 Interventions

FT500 administered once weekly for 3 weeks as a monotherapy

Group III: FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor Experimental Treatment 7 Interventions

FT500 + IL-2 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.

Who Is Running the Clinical Trial?

Fate Therapeutics

Lead Sponsor

Trials

22

Recruited

1,200+