Gender
Female
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Women with recurrent, advanced, platinum resistant ovarian, fallopian tube, and
primary peritoneal cancer that have progressed after receiving standard of care
therapies or are not eligible to receive available therapies with known clinical
benefit will be eligible for the study. Patients must have measurable disease that
can be accurately measured by RECIST 1.1 criteria in at least one dimension as >=
1.0 cm or > 1.5 cm lymph node with computed tomography (CT), ultrasound, or magnetic
resonance imaging (MRI) techniques.
- Platinum resistant is defined as progression of disease within six months of
platinum regimen.
- Patients with BRCA mutations who have completed standard therapies (including
PARP inhibitors) are allowed on this study.
- Patients must be capable of understanding and providing a written informed consent.
- Patients must be 14 days from previous cytotoxic chemotherapy at time of cell
collection.
- Laboratory values must indicate adequate organ function.
- Patients must be at least 28 days post systemic steroids prior to enrollment except
as premedication for contrast allergy and/or other protocol-mandated medication.
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status
score of =< 2.
- Patients must have recovered from major acute infections and/or recent surgical
procedures, and in the opinion of the investigator, not have any significant active
concurrent medical illnesses precluding protocol treatment.
- Negative pregnancy test for women of childbearing potential. Women of childbearing
potential are those who have not been surgically sterilized, are < 60 years old, or
have had menses within the past 12 months.
- Women of childbearing potential must be willing to use 2 methods of contraception
before, during, and at least 4 months after the PRGN-3005 cell infusion.
Exclusion Criteria:
- Patients with any of the following cardiac conditions:
- Symptomatic restrictive cardiomyopathy
- Unstable angina or symptomatic coronary artery disease within 4 months prior to
enrollment
- New York Heart Association functional class III-IV heart failure on active
treatment
- Symptomatic pericardial effusion
- Congestive heart failure
- Clinically significant hypotension.
- Patients with CA 125 =< ULN during screening.
- Patients with history of human immunodeficiency virus (HIV), West Nile, Zika, or
active hepatitis B or C infections.
- Patients with severe, symptomatic ascites requiring diuretics, regular paracentesis,
or other invasive interventions.
- Patients within 28 days of receiving another investigational agent.
- Patients with pulmonary hypertension, pulmonary fibrosis, or restrictive lung
disease, patients with baseline oxygen saturation on room air < 92%, forced
expiratory volume in 1 second (FEV1) =< 50%, or diffusion capacity of the lung for
carbon monoxide (DLco) (corrected) of < 40% will be excluded.
- Women who are pregnant or breast feeding.
- Patients with second malignancy within the last 5 years excluding basal carcinoma of
the skin, squamous carcinoma of the skin, or in situ cervical dysplasia that has
undergone curative therapy.
- Patients with an active autoimmune disease requiring immunosuppressive therapy or
uncontrolled with treatment.
- Patients who are simultaneously enrolled in any other treatment study.
- Clinical or radiological evidence of acute bowel obstruction within 30 days of
signing consent.
- Patients with known or treated brain metastases.
- Patients with an active seizure disorder.
- Any female patient <60 years old who does not meet at least one of the following
criteria will be considered to have reproductive potential:
- Post-menopausal for at least 12 consecutive months (i.e., no menses), or
- Undergone a sterilization procedure (hysterectomy, salpingectomy, or bilateral
oophorectomy; tubal ligation is not considered a sterilization procedure).
Pregnancy test for females of reproductive potential must be negative within 14
days before leukapheresis.