This is phase 2 single arm study evaluating the safety and preliminary efficacy of M-CENK adoptive cell therapy and fixed dose of N-803 in combination with gemcitabine in participants with platinum-resistant high-grade ovarian cancer (HGOC).Up to 20 participants will receive M-CENK (IV) and N-803 (SC) in combination with gemcitabine (IV). Participants will undergo an apheresis procedure for the collection of mononuclear cells (MNCs) at least 1 day prior to Cycle 1 for manufacturing of M-CENK. Starting in Cycle 1, participants will receive gemcitabine and starting in Cycle 2 they will also receive M-CENK and N-803, until no additional M-CENK is available or confirmed PD per iRECIST, unless the participant is potentially deriving benefit per Investigator's assessment. Participants who complete the study treatment or discontinue study treatment will be followed for survival/disease status every 12 weeks (± 2 weeks) for up to 12 months after the last study treatment or until death, lost to follow-up, or withdrawal of consent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Dose: 800 mg/m2 intravenously (IV) Frequency: administered on Day 1, Day 8, and Day 15 of each cycle (every 4 weeks)
Dose: fixed dose of 1.2 mg subcutaneously (SC) Frequency: administered on Day 1 and Day 15 of each cycle starting at Cycle 2 (every 4 weeks) and when the last dose of M-CENK is administered, N-803 will be administered on Days 1 and 15 of the same cycle followed by 3 additional doses, 2 weeks apart (total of 5 N-803 doses).
Dose: 0.15 to 0.75 × 109 cells per infusion intravenously (IV) Frequency: administered on Day 1 of each cycle as long as M-CENK cells are available.
Chan Soon-Shiong Institute for Medicine
El Segundo, California, United States
RECRUITINGHoag
Newport Beach, California, United States
RECRUITINGEvaluate Progression Free Survival (PFS)
Measured by RECIST v1.1 and iRECIST
Time frame: Cycle 1 Day 1 through End of Study, up to 2 years
Evaluate Overall Survival (OS)
Time frame: Cycle 1 Day 1 through End of Study, up to 2 years
Evaluate Objective Response Rate (ORR)
Measured by RECIST v1.1 and iRECIST
Time frame: Cycle 1 Day 1 through End of Study, up to 2 years
Evaluate Duration of Response (DOR)
Measured by RECIST v1.1 and iRECIST
Time frame: From time of first response to the date of disease progression or death, up to 2 years
Evaluate Disease Control Rate (DCR)
Measured by RECIST v1.1 and iRECIST
Time frame: Cycle 1 Day 1 through End of Study, up to 2 years
Evaluate the time to progression or death on the next line of treatment (PFS2) of participants receiving M-CENK adoptive cell therapy and N-803 in combination with gemcitabine.
Measured by RECIST v1.1 and iRECIST and survival status
Time frame: Cycle 1 Day 1 through End of Study, up to 2 years
Evaluate the CA-125 response rate (RR) per Gynecologic Cancer Intergroup (GCIC) CA-125 criteria.
Measured by the CA-125 result
Time frame: Cycle 1 Day 1 through End of Study, up to 2 years
Safety: Evaluate adverse events
Time frame: Apheresis to 30 days after the last dose of study treatment or the end of treatment visit, up to 13 months
Safety: Incidence of clinically significant changes in comprehensive metabolic panel (CMP)
Standard blood chemistry panel made up of 14 separate chemistry measurements so can detect a range of abnormalities in blood sugar, nutrient balance, and liver and kidney health. Each clinical site will use their local laboratory upper limit of normal (ULN) range. The treating investigator will assess each result composing the CMP and determine if each result is within expected normal range or outside of the expected normal range.
Time frame: Screening through Follow-up, up to 2 years
Safety: Incidence of clinically significant changes in Hematology blood panel
Blood test checking the levels for White Blood Cell, Red Blood Cell, Platelets, Hemoglobin, Hematocrit, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils per unit volume. Each clinical site will use their local laboratory upper limit of normal (ULN) range. The treating investigator will assess each component of the Hematology panel and determine if each result is within expected normal range or outside of the expected normal range.
Time frame: Screening through Follow-up, up to 2 years
Safety: Incidence of clinically significant changes in Temperature
Temperature measured in either Fahrenheit or Celsius and for any abnormalities. Each site will assess to determine if temperature is within expected normal range or outside of the expected normal range.
Time frame: Screening through Follow-up, up to 2 years
Safety: Incidence of clinically significant changes in Heart Rate
Heart rate measured in beats/minute. Each site will assess to determine if heart rate is within expected normal range or outside of the expected normal range.
Time frame: Screening through Follow-up, up to 2 years
Safety: Incidence of clinically significant changes in Respiratory Rate
Respiratory rate measured in breaths/minute. Each site will assess to determine if respiratory rate is within expected normal range or outside of the expected normal range.
Time frame: Screening through Follow-up, up to 2 years
Safety: Incidence of clinically significant changes in Blood Pressure
Blood pressure measured in Systolic and Diastolic mmHg. Each site will assess to determine if blood pressure is within expected normal range or outside of the expected normal range.
Time frame: Screening through Follow-up, up to 2 years
Safety: Incidence of clinically significant changes in Oxygen Saturation
A pulse oximeter measures oxygen saturation as a percentage. Determines the ratio of the current levels of oxygenated hemoglobin to deoxygenated hemoglobin. Each site will assess to determine if oxygen saturation is within expected normal range or outside of the expected normal range.
Time frame: Screening through Follow-up, up to 2 years
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