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

Brief Title

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

Official Title

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

Brief 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).

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Maximum Tolerated Doze of FATE-NK100

Secondary Outcome

 Objective Response Rate

Condition

Epithelial Ovarian Cancer

Intervention

FATE-NK100

Study Arms / Comparison Groups

 Arm 1

Description:  FATE-NK100 is a donor-derived NK cell product comprising ex vivo activated effector cells with enhanced anti-tumor activity.
FATE-NK100 is administered to determine the maximum tolerated doze/maximum feasible dose (MTD/MFD).
Interleukin-2 (IL-2) remains the only FDA approved drug that is capable of promoting NK cells activation and survival.
Lymphodepletion with Cyclophosphamide and Fludarabine.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

October 19, 2017

Completion Date

March 10, 2021

Primary Completion Date

March 10, 2021

Eligibility Criteria

        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

               -  Hepatic: AST and ALT ≤ 3 x upper limit of institutional normal

               -  Pulmonary Function: Oxygen saturation ≥ 90% on room air; PFT's required only if
                  symptomatic or prior known impairment - must have pulmonary function >50%
                  corrected DLCO and FEV1

               -  Cardiac Function: LVEF ≥ 40% by echocardiography, MUGA, or cardiac MRI; no
                  uncontrolled angina, severe uncontrolled ventricular arrhythmias, or
                  electrocardiographic evidence of acute ischemia or active conduction system
                  abnormalities

        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

        Exclusion Criteria:

          -  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).

          -  Uncontrolled bacterial, fungal or viral infections with progression of clinical
             symptoms despite therapy

          -  Known history of HIV positivity or active hepatitis C or B - chronic asymptomatic
             viral hepatitis is allowed

          -  Received any investigational agent within the 14 days before the start of study
             treatment (1st dose of fludarabine)

          -  Disease outside of the peritoneal cavity

Gender

Female

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Melissa Geller, MD, MS, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03213964

Organization ID

2016LS186

Responsible Party

Sponsor

Study Sponsor

Masonic Cancer Center, University of Minnesota

Study Sponsor

Melissa Geller, MD, MS, Principal Investigator, Masonic Cancer Center, University of Minnesota

Verification Date

March 2021