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CAR T-cell Therapy

FT536 for Gynecologic Cancers

Phase 1

Recruiting

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

In the presence of a BRCA mutation, must have received a prior PARP inhibitor

Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer meeting minimal prior treatment requirements

Must not have

Currently receiving or likely to require systemic immunosuppressive therapy

Active autoimmune disease requiring systemic immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called FT536 given directly into the abdomen three times a week for one week to treat recurrent gynecologic cancers. Patients will also receive a short course of chemotherapy before

Who is the study for?

This trial is for individuals with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Participants must have had certain prior treatments, including a PARP inhibitor if they have a BRCA mutation and bevacizumab. They need to agree to an intraperitoneal catheter placement and sign up for long-term follow-up. Adequate organ function is required.

What is being tested?

The trial tests FT536 given intraperitoneally alongside lymphodepleting chemotherapy (CY/Flu). It's designed to see how well this treatment works in patients with specific gynecologic cancers that have recurred after previous therapies.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to the genetically modified cell product (FT536), as well as typical chemotherapy-related issues such as fatigue, nausea, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a BRCA mutation and have been treated with a PARP inhibitor.

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My cancer has returned and is in the ovary, fallopian tube, or peritoneum.

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I have previously been treated with bevacizumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on or might need drugs that weaken my immune system.

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I am on medication to suppress my immune system due to an autoimmune disease.

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I have severe asthma and take daily medication for it.

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I have an infection that isn't getting better despite treatment.

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I have previously been treated with enoblituzumab.

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I have a history of HIV or active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Cohort 3: IP FT536 monotherapy 1 x 10^9 cells/doseExperimental Treatment3 Interventions

FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master human induced pluripotent stem cell (iPSC) line with the following engineered elements: a) deletion of the gene encoding CD38 (i.e., CD38 knockout) and expression of the MICA and MICB (MICA/B) chimeric antigen receptor (CAR); b) high-affinity, non-cleavable CD16 receptor; and c) interleukin (IL)-15/IL-15 receptor alpha fusion protein. Participants will receive doses on Day 1, Day 4 and day 8.

Group II: Dose Cohort 2: IP FT536 monotherapy 3 x 10^8 cells/doseExperimental Treatment3 Interventions

Group III: Dose Cohort 1: IP FT536 monotherapy 1 x 10^8 cells/doseExperimental Treatment3 Interventions

Group IV: Dose Cohort -1: IP FT536 monotherapy 3 x 10^6 cells/doseExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

2015