NCT06342986

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
14mo left

Started Jul 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Jul 2024Jun 2027

First Submitted

Initial submission to the registry

March 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 11, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2026

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 27, 2024

Last Update Submit

March 27, 2026

Conditions

Gynecologic CancerOvarian CancerFallopian Tube CancerPrimary Peritoneal Cavity Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    1 year

Secondary Outcomes (3)

  • Progression free survival (PFS)

    6 months

  • Overall survival (OS)

    6 months

  • Overall survival (OS)

    1 year

Study Arms (4)

Dose Cohort -1: IP FT536 monotherapy 3 x 10^6 cells/dose

EXPERIMENTAL

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.

Drug: FT536Drug: FludarabineDrug: CY

Dose Cohort 1: IP FT536 monotherapy 1 x 10^8 cells/dose

EXPERIMENTAL

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.

Drug: FT536Drug: FludarabineDrug: CY

Dose Cohort 2: IP FT536 monotherapy 3 x 10^8 cells/dose

EXPERIMENTAL

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.

Drug: FT536Drug: FludarabineDrug: CY

Dose Cohort 3: IP FT536 monotherapy 1 x 10^9 cells/dose

EXPERIMENTAL

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.

Drug: FT536Drug: FludarabineDrug: CY

Interventions

FT536DRUG

FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master humaninduced pluripotent stem cell (iPSC) line.

Dose Cohort -1: IP FT536 monotherapy 3 x 10^6 cells/doseDose Cohort 1: IP FT536 monotherapy 1 x 10^8 cells/doseDose Cohort 2: IP FT536 monotherapy 3 x 10^8 cells/doseDose Cohort 3: IP FT536 monotherapy 1 x 10^9 cells/dose
FludarabineDRUG

Fludarabine 25 mg/m2 IV given on day -5. Given consecutively with CY.

Dose Cohort -1: IP FT536 monotherapy 3 x 10^6 cells/doseDose Cohort 1: IP FT536 monotherapy 1 x 10^8 cells/doseDose Cohort 2: IP FT536 monotherapy 3 x 10^8 cells/doseDose Cohort 3: IP FT536 monotherapy 1 x 10^9 cells/dose
CYDRUG

CY 300 mg/m2 IV given on day -4. Given consecutively with Fludarabine.

Dose Cohort -1: IP FT536 monotherapy 3 x 10^6 cells/doseDose Cohort 1: IP FT536 monotherapy 1 x 10^8 cells/doseDose Cohort 2: IP FT536 monotherapy 3 x 10^8 cells/doseDose Cohort 3: IP FT536 monotherapy 1 x 10^9 cells/dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer meeting one of the following minimal prior treatment requirements (no limit to the maximum number of prior treatments).
  • Must have received prior bevacizumab.
  • In the presence of a BRCA mutation, must have received a prior PARP inhibitor.
  • Adequate organ function within 14 days (28 days for pulmonary and cardiac) of study treatment (CY/Flu) start
  • Agrees to the placement of an intraperitoneal catheter before the 1st dose of study directed drug (chemotherapy) and remains in place through Day 36 or longer if retreatment is planned. Refer to Section 6.4 if catheter cannot be successfully placed.
  • Agrees to undergo a tumor biopsy if feasible at the time the catheter is placed and removed - Accessible tumor for biopsy is not required for eligibility
  • Must agree to and sign the consent for the companion Long-Term Follow-Up study (CPRC# 2021LS077) to fulfill the FDA recommended 15 years of followup for a genetically modified cell product.

You may not qualify if:

  • Pregnant or breastfeeding or planning on becoming pregnant in the next 6 months. If of childbearing potential (have a uterus and ovaries) and engaged in heterosexual intercourse, must have a negative pregnancy test (serum or urine) within 14 days before the 1st CY/Flu. Patient must agree to use highly effective method of birth control from the screening visit until at least 12 months after the final dose of CY, or at least 4 months after the final dose of FT536, whichever is longer.
  • Currently receiving or likely to require systemic immunosuppressive therapy (e.g., prednisone \>5 mg daily) for any reason from Day -5 to 14 days after the last FT536 infusion) with the exception of corticosteroids as a pre-medication per institutional standard of care - topical and inhaled steroids are permitted.
  • Active autoimmune disease requiring systemic immunosuppressive therapy.
  • History of severe asthma and currently on chronic systemic medications.
  • Uncontrolled bacterial, fungal or viral infections with progression of clinical symptoms despite therapy.
  • Receipt of any biological therapy, chemotherapy, or radiation therapy (except palliative RT), within 2 weeks prior to the first dose of FT536 or five half-lives, whichever is shorter; or any investigational agent within 28 days prior to the first dose of FT536.
  • Live vaccine within 6 weeks prior to start of lympho-conditioning.
  • Known allergy to the following FT536 components: albumin (human) or dimethyl sulfoxide (DMSO).
  • Prior enoblituzumab.
  • Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment. (Refer to Section 5.1.8 regarding history of brain metastases.)
  • Known history of HIV positivity or active hepatitis C or B - chronic asymptomatic viral hepatitis is allowed.
  • Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to patient.
  • Any medical condition or clinical laboratory abnormality that, per investigator judgement, precludes safe participation in and completion of the study or that could affect compliance with protocol conduct or interpretation of results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

fludarabine

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: A minimum of 28 days must separate each Dose Cohort. A minimum of 30 days must separate the 1st and 2nd patient. All patients are assessed for Dose Limiting Toxicity (DLT)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 2, 2024

Study Start

July 11, 2024

Primary Completion

March 26, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)