Epithelial Ovarian CancerPhase 1NCT03213964
Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int
A Phase 1 study testing FATE-NK100 and Interleukin-2 in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- FATE-NK100 and Interleukin-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2017to 10 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
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).
- Being tested
- FATE-NK100, Interleukin-2
- Keywords
- Recurrent, Platinum Resistant, Platinum Sensitive
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FATE-NK100Biological
FATE-NK100 Infusion (Day 0)
The FATE-NK100 product will be placed in approximately 100 cc of 5% human serum albumin.
- Dose Level 1: 1 x 10^7 cells/kg IP
- Dose Level 2: >1x10^7 cells/kg to ≤3x10^7 cells/kg
- Dose Level 3: Complete FATE-NK100 bag (≥3 x 10^7 to ≤ 10 x 10^7 cells/kg)
Interleukin-2Drug
Also called IL-2
Interleukin-2 (begin Day 0): 6 million units three times a week for a total of 6 doses. For patients weighing less than 45 kilograms, the IL-2 will be given at 3 million units/m2 three times a week for 6 doses.
The 1st dose will be given immediately (within 30 minutes) after the FATE-NK100 cell infusion on Day 0 as an inpatient. The remaining doses will be given in an outpatient setting.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 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. Receives: Biological: FATE-NK100; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Doze of FATE-NK100
To determine the maximum tolerated dose/maximum feasible dose (MTD/MFD) of FATE-NK100 when administered via intraperitoneal catheter in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer.
Measured: 1 Year
Secondary outcomes (3)
Objective Response Rate
Incidence of objective response rate (ORR) of the FATE-NK100 treatment
Measured: Day 28
Progression-Free Survival (PFS)
Incidence of progression-free survival of treated patients 6 months post-infusion
Measured: 6 Months
Overall Survival (OS)
Incidence of overall survival of treated patients 6 months post-infusion
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start19 Oct 2017
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Geller, MD, MS, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213964
- Sponsor's protocol ID
- 2016LS186
- Status last verified
- Mar 2021
- First submitted
- 7 Jul 2017
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03213964
- Acronym / sponsor ID
- 2016LS186
- Keywords
- Recurrent, Platinum Resistant, Platinum Sensitive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: FATE-NK100, Drug: Interleukin-2FATE-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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):
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FATE-NK100FATE-NK100 Infusion (Day 0) The FATE-NK100 product will be placed in approximately 100 cc of 5% human serum albumin. * Dose Level 1: 1 x 10^7 cells/kg IP * Dose Level 2: >1x10^7 cells/kg to ≤3x10^7 cells/kg * Dose Level 3: Complete FATE-NK100 bag (≥3 x 10^7 to ≤ 10 x 10^7 cells/kg) | Biological | Arm 1 |
| Interleukin-2Also: IL-2Interleukin-2 (begin Day 0): 6 million units three times a week for a total of 6 doses. For patients weighing less than 45 kilograms, the IL-2 will be given at 3 million units/m2 three times a week for 6 doses. The 1st dose will be given immediately (within 30 minutes) after the FATE-NK100 cell infusion on Day 0 as an inpatient. The remaining doses will be given in an outpatient setting. | Drug | Arm 1 |
Primary outcome
Maximum Tolerated Doze of FATE-NK100
Time frame: 1 Year
To determine the maximum tolerated dose/maximum feasible dose (MTD/MFD) of FATE-NK100 when administered via intraperitoneal catheter in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer.
3 secondary outcomes
Objective Response Rate
Time frame: Day 28
Progression-Free Survival (PFS)
Time frame: 6 Months
Overall Survival (OS)
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Geller, MD, MS principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FATE-NK100 and Interleukin-2 in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Doze of FATE-NK100 (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.