Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
NCT ID: NCT06342986
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
33 participants
INTERVENTIONAL
2024-07-11
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Cohort -1: IP FT536 monotherapy 3 x 10^6 cells/dose
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
FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master humaninduced pluripotent stem cell (iPSC) line.
Fludarabine
Fludarabine 25 mg/m2 IV given on day -5. Given consecutively with CY.
CY
CY 300 mg/m2 IV given on day -4. Given consecutively with Fludarabine.
Dose Cohort 1: IP FT536 monotherapy 1 x 10^8 cells/dose
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
FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master humaninduced pluripotent stem cell (iPSC) line.
Fludarabine
Fludarabine 25 mg/m2 IV given on day -5. Given consecutively with CY.
CY
CY 300 mg/m2 IV given on day -4. Given consecutively with Fludarabine.
Dose Cohort 2: IP FT536 monotherapy 3 x 10^8 cells/dose
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
FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master humaninduced pluripotent stem cell (iPSC) line.
Fludarabine
Fludarabine 25 mg/m2 IV given on day -5. Given consecutively with CY.
CY
CY 300 mg/m2 IV given on day -4. Given consecutively with Fludarabine.
Dose Cohort 3: IP FT536 monotherapy 1 x 10^9 cells/dose
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
FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master humaninduced pluripotent stem cell (iPSC) line.
Fludarabine
Fludarabine 25 mg/m2 IV given on day -5. Given consecutively with CY.
CY
CY 300 mg/m2 IV given on day -4. Given consecutively with Fludarabine.
Interventions
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FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master humaninduced pluripotent stem cell (iPSC) line.
Fludarabine
Fludarabine 25 mg/m2 IV given on day -5. Given consecutively with CY.
CY
CY 300 mg/m2 IV given on day -4. Given consecutively with Fludarabine.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Locations
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University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Deanna Teoh, MD
Role: primary
Other Identifiers
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2023LS185
Identifier Type: -
Identifier Source: org_study_id