FT536 for Gynecologic Cancers

Overseen By Melissa Geller, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Masonic Cancer Center, University of Minnesota

Must not be taking: Immunosuppressants, Systemic steroids

Disqualifiers: Pregnancy, Autoimmune disease, Severe asthma, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

33 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot be on systemic immunosuppressive therapy or have had recent chemotherapy, biological therapy, or radiation therapy. It's best to discuss your specific medications with the trial team.

What is the purpose of this trial?

This is a single center Phase I clinical trial of FT536 administered intraperitoneally (IP) 3 times a week for one week for the treatment of recurrent gynecologic cancers. A short course of outpatient lymphodepleting chemotherapy is given prior to the first dose of FT536 to promote adoptive transfer.

Eligibility Criteria

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.

Inclusion Criteria

My organs are working well enough for treatment.

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

I agree to have a catheter placed inside my belly for the study, and keep it until Day 36 or longer if needed.

Exclusion Criteria

Pregnant or breastfeeding or planning on becoming pregnant in the next 6 months

I have not taken specific medications recently.

I haven't had non-cancerous brain conditions or taken medication for them in the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

A short course of outpatient lymphodepleting chemotherapy is given prior to the first dose of FT536 to promote adoptive transfer

1 week

Treatment

FT536 administered intraperitoneally 3 times a week for one week

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FT536

Trial Overview 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.

Participant Groups

Group I: Dose Cohort 3: IP FT536 monotherapy 1 x 10^9 cells/dose Experimental Treatment 3 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/dose Experimental Treatment 3 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 III: Dose Cohort 1: IP FT536 monotherapy 1 x 10^8 cells/dose Experimental Treatment 3 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 IV: Dose Cohort -1: IP FT536 monotherapy 3 x 10^6 cells/dose Experimental Treatment 3 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.

FT536 is already approved in United States for the following indications:

Approved in United States as FT536 for:

• None approved yet; currently in Phase 1 clinical trials for advanced solid tumors including ovarian cancer, fallopian tube cancer, and primary peritoneal cancer

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+