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Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int

Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Interleukin-2 in Women With Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

NCT03213964•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

This is a Phase I trial to determine the maximum tolerated dose/maximum feasible dose (MTD/MFD) of a single infusion of FATE-NK100 via intra-peritoneal catheter in women with recurrent ovarian, fallopian tube or primary peritoneal cancer meeting one of the following minimal prior treatment requirement: * Platinum resistant: may receive FATE-NK100 as 2nd line (as 1st salvage therapy). Platinum resistant is defined as disease that has responded to initial chemotherapy but demonstrates recurrence within a relatively short period of time (\< 6 months) following the completion of treatment. * Platinum sensitive: may receive FATE-NK100 as 3rd line therapy (as 2nd salvage therapy). Platinum sensitive is defined as the recurrence of active disease in a patient who has achieved a documented response to initial platinum-based treatment and has been off therapy for an extended period of time (≥ 6 months).

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer meeting one of the following minimal prior treatment requirement (no limit to the maximum number of prior treatments):
•* Platinum Resistant: may receive FATE-NK100 as 2nd line (as 1st salvage therapy) with platinum resistant is defined as disease that has responded to initial chemotherapy but demonstrates recurrence within a relatively short period of time (\< 6 months) following the completion of treatment.
•* Platinum Sensitive: may receive FATE-NK100 as 3rd line therapy (as 2nd salvage therapy) with platinum sensitive is defined as the recurrence of active disease in a patient who has achieved a documented response to initial platinum-based treatment and has been off therapy for an extended period of time (≥ 6 months).
•Measurable disease per RECIST within the abdomen and pelvis. Extra-peritoneal disease is permitted; however each lesion must be \< 5 cm at the largest diameter.
•Available HLA haploidentical or better but not fully HLA-matched (2/4 or 3/4 antigens) related donor (aged 18 to 75 years) with donor/recipient match based on a minimum of intermediate resolution DNA based Class I typing of the A and B locus who is CMV seropositive.
•At least 18 years of age, but not older than 75 years
•GOG Performance Status 0, 1, or 2
•Adequate organ function within 14 days of study registration (28 days for pulmonary and cardiac) defined as:
•* Hematologic: platelets ≥ 80,000 x 109/L and hemoglobin ≥ 9 g/dL, unsupported by transfusions; absolute neutrophil count (ANC) ≥ 1000 x 109/L, unsupported by G-CSF or granulocytes
•* Creatinine: Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73m2 per current institutional calculation formula
+3 more criteria

Exclusion Criteria

•Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to FATE-NK100 cell infusion (excluding preparative regimen pre-medications)
•Agrees to the placement of an intraperitoneal port before the start of chemotherapy and remains in place through Day 28 or longer
•Washout period of at least 14 days after any approved or experimental tumor directed therapy prior to start of cyclophosphamide and fludarabine
•If history of brain metastases must be stable for at least 3 months after treatment - A brain CT scan or MRI is only be required in subjects with known brain metastases at the time of enrollment or in subjects with clinical signs or symptoms suggestive of brain metastases
•Voluntary written consent prior to the performance of any research related procedures
•Untreated brain metastases
•Myocardial Infarction (MI) within the previous 6 months
•Active autoimmune disease requiring systemic immunosuppressive therapy
•History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
•New or progressive pulmonary infiltrates on screening chest X-ray or chest CT scan unless cleared for study by Pulmonary. Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).
+4 more criteria

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

October 19, 2017

Primary Completion Date

March 10, 2021

Completion Date

March 10, 2021

Last Updated

March 12, 2021

Enrollment

ACTUAL participants

Conditions

Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer

Interventions

FATE-NK100

BIOLOGICAL

Interleukin-2

DRUG

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

NCT05281471

Platinum-resistant Ovarian CancerPlatinum-refractory Ovarian Cancer+5 more

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RECRUITINGPHASE1/PHASE2

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int

Inclusion Criteria

Exclusion Criteria

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery

An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study

A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab