9 Participants NeededMy employer runs this trial

FT536 for Glioblastoma

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Masonic Cancer Center, University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FT536 for individuals with glioblastoma, a type of brain cancer. Researchers aim to determine if FT536, injected directly into the tumor, can benefit patients whose cancer has returned after initial treatment. The trial examines three different dose levels to identify the safest and most effective one. Suitable candidates for this trial have experienced a recurrence of glioblastoma after previous treatments and can undergo another surgical tumor removal. As a Phase 1 trial, this research focuses on understanding how FT536 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of dexamethasone 2mg daily or less, and you cannot be on systemic immunosuppressive therapy.

Is there any evidence suggesting that FT536 is likely to be safe for humans?

Research has shown that FT536 has been studied for its safety in treating certain types of tumors. Previous studies found that FT536 can effectively target specific tumor markers. For example, one study found that FT536 was well-tolerated by patients, with no severe side effects directly linked to the treatment.

The main goal of these studies is to find a safe dose and understand any side effects. Early results suggest that FT536 is generally safe for humans, as it mainly targets tumor cells. However, since this is an early-phase study, researchers continue to gather safety data.

Prospective participants should know that researchers closely monitor for any safety issues to ensure the treatment is well-tolerated. Always consult a healthcare provider to discuss any concerns.12345

Why do researchers think this study treatment might be promising for glioblastoma?

Unlike the standard treatments for glioblastoma, which often include surgery, radiation, and chemotherapy, FT536 is an innovative cell therapy. Researchers are excited about FT536 because it harnesses engineered natural killer (NK) cells to specifically target and destroy cancer cells. This method could potentially lead to more precise attacks on the tumor, reducing damage to healthy brain tissue. Furthermore, FT536 may offer a novel mechanism of action that differs from traditional therapies, which could improve treatment outcomes for patients with this aggressive brain cancer.

What evidence suggests that FT536 might be an effective treatment for glioblastoma?

Research shows that FT536, a new treatment tested in this trial, holds promise for targeting certain tumors. FT536 uses CAR NK cells, specially designed immune cells that locate and attack tumors with MICA/B proteins. Early results suggest these cells effectively interact with these tumor types in lab and animal studies. Additionally, other research has shown that similar methods have helped glioblastoma patients live longer and achieve better outcomes compared to traditional treatments. While detailed human data on FT536 is still being gathered, its mechanism offers hope for treating aggressive brain tumors like glioblastoma.12346

Are You a Good Fit for This Trial?

This trial is for adults aged 18–75 with a confirmed diagnosis of WHO Grade 4 astrocytoma (including glioblastoma) that has come back once or twice and can be surgically removed again. Participants must have finished standard treatments, be able to get MRIs, have good organ function, and use effective birth control if needed.

Inclusion Criteria

* Participants of childbearing potential (POCBP) or with partners of childbearing potential must use a highly effective form of contraception from the time of the screening visit until at least 3 months after the dose of FT536.
I am between 18 and 75 years old.
I am not receiving any other curative treatments for my condition.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

FT536 is administered once intratumorally following biopsy confirmation of recurrence

1 day
1 visit (in-person)

Surgical Intervention

Maximum safe surgical resection and post-operative safety MR brain imaging

7-14 days after treatment
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • FT536

Trial Overview

The study is testing FT536, a new treatment injected directly into the brain tumor during surgery in patients with recurrent grade 4 astrocytoma. This is an early-phase (Phase I), single-center trial focused on safety and feasibility after surgical removal of the tumor.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Dose Level Cohort 2Experimental Treatment3 Interventions
Group II: Dose Level Cohort 1Experimental Treatment3 Interventions
Group III: Dose Level Cohort -1Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials
285
Recruited
15,700+

Fate Therapeutics

Industry Sponsor

Trials
22
Recruited
1,200+

Citations

First-in Cancer-Type Phase I Study of FT536 for Recurrent ...

This is a single center, first-in cancer-type phase I clinical trial of FT536 for adult patients with recurrent WHO Grade 4 astrocytoma, ...

Study Details | NCT05395052 | FT536 Monotherapy and in ...

This is a Phase 1 dose-finding study of FT536 given in combination with a monoclonal antibody following lymphodepletion in participants with advanced solid ...

ImmunityBio Reports Median Overall Survival Not Yet ...

Five-year survival rates remain below 10 percent, underscoring the limited impact of existing therapeutic approaches. A defining but ...

Combining FT536, a pan-Tumor Targeting CAR NK Cell ...

FT536 3MICA/B CAR expressing iNK cells provide broad tumor reactivity and in vivo efficacy. ... Data as of 27Sep2022. *Disease progression due to new lesion.

FT536 for Glioblastoma · Recruiting Participants for Phase ...

This is a single center, first-in cancer-type phase I clinical trial of FT536 for adult patients with recurrent WHO Grade 4 astrocytoma, ...

FT536 / Fate Therapeutics

These data demonstrate successful targeting of MICA/B positive tumors by FT536 can be augmented by mAb and radiation therapies as first-of-kind ...