MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Gr... | NCT03585764

ID	Type	Description	Link
1R01CA260902	U.S. NIH Grant/Contract		View source

Name	Class
National Cancer Institute (NCI)	NIH
OvaCure Fundation	UNKNOWN
Alliance for Cancer Gene Therapy	OTHER
Ovarian Cancer Alliance of Greater Cincinnati

Label	Type	Description	Intervention Names
Cohort 1: MOv19-BBz CAR T cells without chemo	Experimental	Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy.	Drug: MOv19-BBz CAR T cells Device: Alpha Folate Receptor expression test
Cohort 2: MOv19-BBz CAR T cells after chemo	Experimental	Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine.	Drug: MOv19-BBz CAR T cells Device: Alpha Folate Receptor expression test
Cohort 3: MOv19-BBz CAR T cells after chemo	Experimental	Cohort 3: (n=3 to 6 subjects): Single infusion of 1-3x108 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine.	Drug: MOv19-BBz CAR T cells Device: Alpha Folate Receptor expression test
Cohort-1: without chemo;only if dose de-escalation required	Experimental	Cohort -1: (n= 3 to 6 subjects): Single Infusion of 1-3x106 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. Up to 6 subjects will be infused in Cohort -1 with ≤ 1 DLT/6 subjects to establish the MTD.

Name	Type	Description	Arm Group Labels	Other Names
MOv19-BBz CAR T cells	Drug	intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy.

Measure	Description	Time Frame
Number of Study Subjects With Treatment-related Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0	For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study.	Up to 34 months
Manufacturing Feasibility	Manufacturing feasibility is determined based on the "manufacturing failures" products. The number of manufactured products that do not meet release criteria for vector transduction efficiency, CART+ cell number, T cell purity, viability, and sterility will be determined and defined as "manufacturing failures".	8 weeks
Clinical Feasibility	Clinical feasibility is defined as the proportion of subjects enrolled on this protocol who do not receive MOv19-BBz CAR T cells. Reasons for this occurrence include rapid clinical deterioration or death, and subject withdrawal.	8 weeks

Measure	Description	Time Frame
Progression-free Survival (PFS)	PFS will be evaluated up to 5 years post-infusion or until subjects initiate a cancer-related therapy	Up to 33 months
Overall Response Rates (ORR)	ORR is the proportion of subjects with a best response of CR or PR based on RECIST 1.1, as compared to baseline. ORR will be evaluated up to 5 years post-infusion or until subjects initiate a cancer-related therapy.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed persistent or recurrent stage II to IV high grade serous epithelial ovarian, fallopian tube or primary peritoneal carcinoma. Disease can be platinum-sensitive or platinum-resistant.
Failure of at least two prior chemotherapy regimens for advanced stage disease. Prior therapies against PD-1 or PDL-1 are permissible.
Confirmation of tumor aFR expression (≥70% of tumor cells with ≥2+ aFR staining).
Subjects must have measureable disease as defined by RECIST 1.1 criteria.
Patients with asymptomatic CNS metastases that have been treated and are off steroids are allowed. They must meet the following at the time of eligibility confirmation by physician-investigator:
1. No concurrent treatment for the CNS disease
2. No progression of CNS metastasis on brain MRI at screening
3. No evidence of leptomeningeal disease or cord compression
Patients ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Satisfactory organ and bone marrow function as defined by the following:

i. Absolute neutrophil count ≥ 1,000/μl ii. Platelets ≥75,000/μl iii. Hemoglobin ≥ 9 g/dL iv. Total bilirubin ≤ 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor v. Creatinine ≤ 1.5x the institutional normal upper limit vi. Albumin ≥2 vii. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5x the institutional normal upper limit viii. Cardiac ejection fraction of ≥40%
Blood coagulation parameters: PT such that international normalized ratio (INR) is ≤ 1.5 and a PTT ≤ 1.2 time the upper limit of normal unless the patient is therapeutically anti-coagulated for history of cancer-related thrombosis and has stable coagulation parameters.
Provides written informed consent.
Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol Section 4.3.

Exclusion Criteria:

High grade serous ovarian, fallopian, or primary peritoneal cancer that is platinum refractory, defined as disease that has clinical or radiographic progression on platinum-based chemotherapy, as per the discretion of the treating physician.
Patients with symptomatic CNS metastases are excluded.
Participation in a therapeutic investigational study within 4 weeks prior to eligibility confirmation by physician-investigator, or anticipated treatment with another investigational product while on study. This refers to non-commercially approved investigational drugs different than those used in this protocol.
Active invasive cancer other than ovarian cancers. Patients with active non-invasive cancers (such as non-melanoma skin cancer, superficial cervical and bladder cancer) are not excluded.
HIV infection
Hepatitis B or hepatitis C infection
Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to >/= 10 mg of prednisone. Patients with autoimmune neurologic diseases (such as multiple sclerosis) will be excluded.
Patients with active and uncontrolled infection.
Planned concurrent treatment with systemic high dose corticosteroids. Patients may be on a stable low dose of steroids (<10 mg daily equivalent of prednisone). Corticosteroids treatment as anti-emetic prophylaxis on the day of lymphodepleting chemotherapy administration is allowed per institutional guidance. The use of topical and/or inhaled steroids are not exclusionary.
Patients requiring supplemental oxygen therapy.
Prior therapy with lentiviral gene modified cells.
History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
Any ascites requiring therapeutic drainage within 4 weeks prior to eligibility confirmation by physician-investigator.
Pregnant or breastfeeding women.
Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the physician-investigator, would make the patient inappropriate for entry into the study.

Name	Affiliation	Role
Payal D Shah, MD	University of Pennsylvania	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania Health System		Philadelphia	Pennsylvania	19104	United States

PubMed Identifier	Type	Citation	Retractions
42068103	Derived	Wang L, Cao Y, Ren Y, Zhang Y, Wang L. Different Immune Cells Modified With Chimeric Antigen Receptors Are Being Applied to Ovarian Cancer: Which Is the Most Effective? Cancer Med. 2026 May;15(5):e71897. doi: 10.1002/cam4.71897.

ID	Title	Description
FG000	Cohort 1: MOv19-BBz CAR T Cells Without Chemo	Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 9, 2023

Arm/Group Information

ID	Title	Description
BG000	Cohort 1: MOv19-BBz CAR T Cells Without Chemo	Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
BG001	Cohort 2: MOv19-BBz CAR T Cells After Chemo	Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
BG002	Cohort 3: MOv19-BBz CAR T Cells After Chemo	Cohort 3: (n=3 to 6 subjects): Single infusion of 1-3x108 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
BG003	Cohort-1: Without Chemo;Only if Dose De-escalation Required	Cohort -1: (n= 3 to 6 subjects): Single Infusion of 1-3x106 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. Up to 6 subjects will be infused in Cohort -1 with ≤ 1 DLT/6 subjects to establish the MTD. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG0013 BG0025 BG0030 BG00411

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Study Subjects With Treatment-related Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0

For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study.

No participants were enrolled in cohort 3

Posted

Count of Participants

Participants

Up to 34 months

ID	Title	Description
OG000	Cohort 1: MOv19-BBz CAR T Cells Without Chemo	Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
OG001	Cohort 2: MOv19-BBz CAR T Cells After Chemo	Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
OG002	Cohort 3: MOv19-BBz CAR T Cells After Chemo	Cohort 3: (n=3 to 6 subjects): Single infusion of 1-3x108 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
OG003	Cohort-1: Without Chemo;Only if Dose De-escalation Required	Cohort -1: (n= 3 to 6 subjects): Single Infusion of 1-3x106 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. Up to 6 subjects will be infused in Cohort -1 with ≤ 1 DLT/6 subjects to establish the MTD. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.

Units	Counts
Participants	OG0003 OG0013 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0013 OG0023 OG003

Primary

Manufacturing Feasibility

Manufacturing feasibility is determined based on the "manufacturing failures" products. The number of manufactured products that do not meet release criteria for vector transduction efficiency, CART+ cell number, T cell purity, viability, and sterility will be determined and defined as "manufacturing failures".

No participants were enrolled in cohort -1

Posted

Number

Product manufacture failures

8 weeks

ID	Title	Description
OG000	Cohort 1: MOv19-BBz CAR T Cells Without Chemo	Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
OG001	Cohort 2: MOv19-BBz CAR T Cells After Chemo	Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.

Primary

Clinical Feasibility

Clinical feasibility is defined as the proportion of subjects enrolled on this protocol who do not receive MOv19-BBz CAR T cells. Reasons for this occurrence include rapid clinical deterioration or death, and subject withdrawal.

No participants were enrolled in cohort -1. Thirty five (35) participants were enrolled in the study but they screen failed and did not receive MOv19-BBz CAR T cell.

Posted

Number

Participants who didn't receive CART cel

8 weeks

ID	Title	Description
OG000	Cohort 1: MOv19-BBz CAR T Cells Without Chemo	Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
OG001	Cohort 2: MOv19-BBz CAR T Cells After Chemo	Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.

Secondary

Progression-free Survival (PFS)

PFS will be evaluated up to 5 years post-infusion or until subjects initiate a cancer-related therapy

No participants were enrolled in Cohort -1

Posted

Median

Full Range

Days

Up to 33 months

ID	Title	Description
OG000	Cohort 1: MOv19-BBz CAR T Cells Without Chemo	Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
OG001	Cohort 2: MOv19-BBz CAR T Cells After Chemo	Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.

Secondary

Overall Response Rates (ORR)

ORR is the proportion of subjects with a best response of CR or PR based on RECIST 1.1, as compared to baseline. ORR will be evaluated up to 5 years post-infusion or until subjects initiate a cancer-related therapy.

No participants were enrolled in Cohort -1

Posted

Count of Participants

Participants

Up to 33 months

ID	Title	Description
OG000	Cohort 1: MOv19-BBz CAR T Cells Without Chemo	Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
OG001	Cohort 2: MOv19-BBz CAR T Cells After Chemo	Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.

Secondary

Overall Survival (OS)

Overall survival is defined as the time from the date of the infusion to the date of death due to any reason. OS will be evaluated up to 15 years post-infusion.

No participants were enrolled in Cohort -1

Posted

Median

Full Range

Days

Up to 33 months

ID	Title	Description
OG000	Cohort 1: MOv19-BBz CAR T Cells Without Chemo	Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
OG001	Cohort 2: MOv19-BBz CAR T Cells After Chemo	Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: MOv19-BBz CAR T Cells Without Chemo	Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.	3	3	1	3	3	3
EG001	Cohort 2: MOv19-BBz CAR T Cells After Chemo	Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.	2	3	2	3	3	3
EG002	Cohort 3: MOv19-BBz CAR T Cells After Chemo	Cohort 3: (n=3 to 6 subjects): Single infusion of 1-3x108 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.	3	5	4	5	4	5
EG003	Cohort-1: Without Chemo;Only if Dose De-escalation Required	Cohort -1: (n= 3 to 6 subjects): Single Infusion of 1-3x106 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. Up to 6 subjects will be infused in Cohort -1 with ≤ 1 DLT/6 subjects to establish the MTD. MOv19-BBz CAR T cells: intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy. Alpha Folate Receptor expression test: Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.	0	0	0	0	0	0

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG0030 events0 affected0 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected5 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Cytokine release syndrome	Immune system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0023 events3 affected5 at risk EG003
Sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Platelet count decreased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other (Acute myeloid leukemia)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected3 at risk EG0022 events2 affected5 at risk EG0030 events0 affected0 at risk
Lymph node pain	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected3 at risk EG0023 events2 affected5 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0023 events2 affected5 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected3 at risk EG0028 events4 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected3 at risk EG0024 events3 affected5 at risk EG003
Chills	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Edema limbs	General disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0002 events2 affected3 at risk EG0012 events2 affected3 at risk EG0022 events2 affected5 at risk EG003
Fever	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Flu like symptoms	General disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk EG003
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Pain	General disorders	Systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk EG003
Shingles	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Injury, poisoning and procedural complications - Other (Catheter site pain)	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Injury, poisoning and procedural complications - Other (Citrate reaction)	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected3 at risk EG0012 events2 affected3 at risk EG0022 events2 affected5 at risk EG003
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected5 at risk EG003
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0022 events1 affected5 at risk EG003
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Blood bilirubin increased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected5 at risk EG003
Creatinine increased	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0002 events2 affected3 at risk EG0014 events3 affected3 at risk EG0025 events4 affected5 at risk EG003
Neutrophil count decreased	Investigations	Systematic Assessment	EG0002 events2 affected3 at risk EG0013 events3 affected3 at risk EG0027 events3 affected5 at risk EG003
Platelet count decreased	Investigations	Systematic Assessment	EG0002 events2 affected3 at risk EG0011 events1 affected3 at risk EG0023 events2 affected5 at risk EG003
Weight loss	Investigations	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events1 affected5 at risk EG003
White blood cell decreased	Investigations	Systematic Assessment	EG0002 events2 affected3 at risk EG0014 events3 affected3 at risk EG0027 events4 affected5 at risk EG003
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0023 events2 affected5 at risk EG003
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected5 at risk EG003
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0023 events3 affected5 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected3 at risk EG0024 events3 affected5 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected3 at risk EG0022 events1 affected5 at risk EG003
Hypomagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected3 at risk EG0022 events2 affected5 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0024 events3 affected5 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0022 events2 affected5 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Depressed level of consciousness	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0024 events3 affected5 at risk EG003
Neuralgia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Paresthesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Presyncope	Nervous system disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk EG003
Tremor	Nervous system disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected5 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Sore throat	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected5 at risk EG003
Skin and subcutaneous tissue disorders - Other (Morbilliform eruption)	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk EG003
Hypotension	Vascular disorders	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected3 at risk EG0023 events1 affected5 at risk EG003
Thromboembolic event	Vascular disorders	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk EG003

ID	Term
D010051	Ovarian Neoplasms
D005185	Fallopian Tube Neoplasms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D005184	Fallopian Tube Diseases