This study is NOT currently recruiting participants.
Number
001582-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Fetuses;Pregnant Women;Neonates;Children
Keywords
MUC16; IL15; Leukapheresis; Lymphodepletion; Ovarian Cancer; platinum resistant
Recruitment Keyword(s)
None
Condition(s)
Recurrent, advanced, platinum resistant ovarian cancer; Recurrent, advanced, platinum resistant fallopian tube cancer; Recurrent, advanced, platinum resistant primary peritoneal cancer; Recurrent, advanced, ovarian cancer; Recurrent, advanced, fallopian tube cancer; Recurrent, advanced, primary peritoneal cancer
Investigational Drug(s)
PRGN-3005 T Cells
Investigational Device(s)
Intervention(s)
Biological/Vaccine: PRGN-3005 UltraCAR-T Cells Drug: Cyclophosphamide Drug: Mesna
Supporting Site
National Cancer Institute
Ovarian cancer is often already advanced when diagnosed. About 80% of people with these cancers respond to treatments at first, but these cancers often come back (recur) and stop responding to treatment. For some ovarian cancers, 5-year survival rates are as low as 4.5%.
Objective:
To test a drug (PRGN-3005) in people with ovarian cancer.
Eligibility:
Women aged 18 years and older with recurrent ovarian cancer that has not responded to treatment.
Design:
Participants will be screened. They will have imaging scans and tests of their heart and lungs.
PRGN-3005 uses the participant s own T cells (a type of white blood cell), which are genetically changed to treat cancer. First, participants will undergo leukapheresis: Blood will be drawn from a needle in an arm. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a second needle.
Participants will be given drugs to weaken their immune system; this will help the PRGN-3005 cells to grow. Participants will receive 2 drugs through a tube attached to a needle inserted into a vein in the arm. This process takes 2 days. Then participants will rest at least 2 more days.
PRGN-3005 made from a participant s own cells will be infused into their blood. This may be done via a vein in the arm or a tube surgically inserted in the abdomen.
Participants will stay in the clinic at least 48 hours after the treatment.
Some participants may receive PRGN-3005 again 1 to 4 weeks later.
Follow-up visits will continue for 12 months. Long-term follow-up will continue for 5 years.
--Back to Top--
INCLUSION CRITERIA: -Women with recurrent, advanced, platinum resistant ovarian, fallopian tube, and primary peritoneal cancer that has 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. --Platinum resistant is defined as progression of disease within six months of platinum regimen. --Subjects with BRCA mutations who have completed standard therapies (including PARP inhibitors) are allowed on this study. --Subjects enrolled in the IV arm 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 for lymph nodes with CT, ultrasound, or MRI techniques. Note that if an excisional biopsy was performed that removed the sole site of measurable disease, the subject will not be eligible for the study. --Subjects enrolled in the dual delivery IV + IP sub-study must have measurable disease that can be accurately measured by RECIST 1.1 criteria and must have <=1.0 cm residual disease or 1.5 cm for lymph nodes to be eligible for this sub-study. Note that if an excisional biopsy was performed that removed the sole site of measurable disease, the subject will not be eligible for the study. -Subjects must be capable of understanding and providing a written informed consent. -Subjects must be 18 years of age or older of any race or ethnicity. -Subjects must be at least 14 days from previous cytotoxic chemotherapy at time of apheresis. -Laboratory values within 30 Days of signing consent: --CA 125 > 2 x institutional upper limit of normal (IULN) --Serum creatinine <=1.8 mg/dL --AST/ALT <=2.5 x ULN and bilirubin <=1.5 ULN --WBC >=3000/mm3 --Lymphocytes >=800/mm3 --Hemoglobin >= 10 g/dl --Platelets >= 75,000/mm3 -LVEF must be >50% within 60 days of the estimated initial PRGN-3005 cell infusion. -Subjects must be at least 28 days post systemic steroids prior to enrollment except as premedication for contrast allergy and/or other protocol mandated medication. -Subjects must have ECOG Performance Status Score of <= 2. -Subjects 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. Note: 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. -For subjects enrolled in the dual delivery IV + IP sub-study who do not have presence of at least small ascites, subject must be willing to have an IP catheter placed for administration of PRGN-3005 and collection of peritoneal fluid. EXCLUSION CRITERIA: -Subjects 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 -Prior treatment with licensed or investigational MUC16 targeting monoclonal antibody or antibody drug conjugate within 6 months or apheresis. -Subjects who have received more than 4 lines of chemotherapy. (maintenance is not considered a second line) -Subjects with CA125 <=2 x institutional upper limit of normal (IULN) during screening. -Subjects with history of HIV, West Nile, Zika, or active Hepatitis B or C infections. -Subjects with severe, symptomatic ascites requiring diuretics, regular paracentesis, or other invasive interventions. -Subjects within 28 days of receiving another investigational agent. -Subjects with pulmonary hypertension, pulmonary fibrosis, or restrictive lung disease, subjects with baseline oxygen saturation on room air < 92%, FEV1 <= 50% or DL infinity (corrected) of <40% will be excluded. -Women who are pregnant or breast feeding. -Subjects 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. -Subjects with an active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment. -Subjects who are simultaneously enrolled in any other treatment study. -Subjects who have current signs and/or symptoms of bowel obstruction or signs and/or symptoms of a bowel obstruction within 3 months prior to starting treatment. -Subjects with history of intra-abdominal abscess within the past 3 months. -Subjects with history of gastrointestinal perforation. (ex. history of symptomatic diverticular disease, confirmed by CT or colonoscopy) -Subjects with intraparenchymal lung metastases. Subjects with pleural effusions will not be excluded and subjects with intraparenchymal liver disease and subjects with retroperitoneal disease are allowed on the study. -Subjects with known or treated brain metastases. -Subjects with an active seizure disorder.
-Women with recurrent, advanced, platinum resistant ovarian, fallopian tube, and primary peritoneal cancer that has 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.
--Platinum resistant is defined as progression of disease within six months of platinum regimen.
--Subjects with BRCA mutations who have completed standard therapies (including PARP inhibitors) are allowed on this study.
--Subjects enrolled in the IV arm 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 for lymph nodes with CT, ultrasound, or MRI techniques. Note that if an excisional biopsy was performed that removed the sole site of measurable disease, the subject will not be eligible for the study.
--Subjects enrolled in the dual delivery IV + IP sub-study must have measurable disease that can be accurately measured by RECIST 1.1 criteria and must have <=1.0 cm residual disease or 1.5 cm for lymph nodes to be eligible for this sub-study. Note that if an excisional biopsy was performed that removed the sole site of measurable disease, the subject will not be eligible for the study.
-Subjects must be capable of understanding and providing a written informed consent.
-Subjects must be 18 years of age or older of any race or ethnicity.
-Subjects must be at least 14 days from previous cytotoxic chemotherapy at time of apheresis.
-Laboratory values within 30 Days of signing consent:
--CA 125 > 2 x institutional upper limit of normal (IULN)
--Serum creatinine <=1.8 mg/dL
--AST/ALT <=2.5 x ULN and bilirubin <=1.5 ULN
--WBC >=3000/mm3
--Lymphocytes >=800/mm3
--Hemoglobin >= 10 g/dl
--Platelets >= 75,000/mm3
-LVEF must be >50% within 60 days of the estimated initial PRGN-3005 cell infusion.
-Subjects must be at least 28 days post systemic steroids prior to enrollment except as premedication for contrast allergy and/or other protocol mandated medication.
-Subjects must have ECOG Performance Status Score of <= 2.
-Subjects 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.
Note: 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.
-For subjects enrolled in the dual delivery IV + IP sub-study who do not have presence of at least small ascites, subject must be willing to have an IP catheter placed for administration of PRGN-3005 and collection of peritoneal fluid.
EXCLUSION CRITERIA:
-Subjects 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
-Prior treatment with licensed or investigational MUC16 targeting monoclonal antibody or antibody drug conjugate within 6 months or apheresis.
-Subjects who have received more than 4 lines of chemotherapy. (maintenance is not considered a second line)
-Subjects with CA125 <=2 x institutional upper limit of normal (IULN) during screening.
-Subjects with history of HIV, West Nile, Zika, or active Hepatitis B or C infections.
-Subjects with severe, symptomatic ascites requiring diuretics, regular paracentesis, or other invasive interventions.
-Subjects within 28 days of receiving another investigational agent.
-Subjects with pulmonary hypertension, pulmonary fibrosis, or restrictive lung disease, subjects with baseline oxygen saturation on room air < 92%, FEV1 <= 50% or DL infinity (corrected) of <40% will be excluded.
-Women who are pregnant or breast feeding.
-Subjects 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.
-Subjects with an active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment.
-Subjects who are simultaneously enrolled in any other treatment study.
-Subjects who have current signs and/or symptoms of bowel obstruction or signs and/or symptoms of a bowel obstruction within 3 months prior to starting treatment.
-Subjects with history of intra-abdominal abscess within the past 3 months.
-Subjects with history of gastrointestinal perforation. (ex. history of symptomatic diverticular disease, confirmed by CT or colonoscopy)
-Subjects with intraparenchymal lung metastases. Subjects with pleural effusions will not be excluded and subjects with intraparenchymal liver disease and subjects with retroperitoneal disease are allowed on the study.
-Subjects with known or treated brain metastases.
-Subjects with an active seizure disorder.
Principal Investigator
Referral Contact
For more information: