Trial Outcomes & Findings for MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT03585764)

Last Updated: 2025-03-26

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

46 participants

Primary outcome timeframe

Up to 34 months

Results posted on

2025-03-26

Participant Flow

35 Subjects were screen failure and were not assigned to a cohort.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	3	3	5
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	3	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Death	3	2	3
Overall Study Lost to Follow-up	0	1	0
Overall Study Physician Decision	0	0	2

Baseline Characteristics

MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: MOv19-BBz CAR T Cells Without Chemo n=3 Participants 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.	Cohort 2: MOv19-BBz CAR T Cells After Chemo n=3 Participants 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.	Cohort 3: MOv19-BBz CAR T Cells After Chemo n=5 Participants 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.	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.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	—	11 participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 34 months

Population: No participants were enrolled in cohort 3

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

Outcome measures

Outcome measures
Measure	Cohort 1: MOv19-BBz CAR T Cells Without Chemo n=3 Participants 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.	Cohort 2: MOv19-BBz CAR T Cells After Chemo n=3 Participants 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.	Cohort 3: MOv19-BBz CAR T Cells After Chemo n=3 Participants 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.	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.
Number of Study Subjects With Treatment-related Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0	3 Participants	3 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: No participants were enrolled in cohort -1

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".

Outcome measures

Outcome measures
Measure	Cohort 1: MOv19-BBz CAR T Cells Without Chemo n=3 Participants 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.	Cohort 2: MOv19-BBz CAR T Cells After Chemo n=3 Participants 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.	Cohort 3: MOv19-BBz CAR T Cells After Chemo n=5 Participants 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.	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.
Manufacturing Feasibility	0 Product manufacture failures	0 Product manufacture failures	0 Product manufacture failures	—

PRIMARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: MOv19-BBz CAR T Cells Without Chemo n=3 Participants 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.	Cohort 2: MOv19-BBz CAR T Cells After Chemo n=3 Participants 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.	Cohort 3: MOv19-BBz CAR T Cells After Chemo n=5 Participants 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.	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.
Clinical Feasibility	0 Participants who didn't receive CART cel	0 Participants who didn't receive CART cel	2 Participants who didn't receive CART cel	—

SECONDARY outcome

Timeframe: Up to 33 months

Population: No participants were enrolled in Cohort -1

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

Outcome measures

Outcome measures
Measure	Cohort 1: MOv19-BBz CAR T Cells Without Chemo n=3 Participants 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.	Cohort 2: MOv19-BBz CAR T Cells After Chemo n=3 Participants 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.	Cohort 3: MOv19-BBz CAR T Cells After Chemo n=3 Participants 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.	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.
Progression-free Survival (PFS)	42 Days Interval 28.0 to 86.0	80 Days Interval 74.0 to 177.0	21 Days Interval 18.0 to 64.0	—

SECONDARY outcome

Timeframe: Up to 33 months

Population: No participants were enrolled in Cohort -1

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.

Outcome measures

Outcome measures
Measure	Cohort 1: MOv19-BBz CAR T Cells Without Chemo n=3 Participants 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.	Cohort 2: MOv19-BBz CAR T Cells After Chemo n=3 Participants 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.	Cohort 3: MOv19-BBz CAR T Cells After Chemo n=3 Participants 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.	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.
Overall Response Rates (ORR)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 33 months

Population: No participants were enrolled in Cohort -1

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.

Outcome measures

Outcome measures
Measure	Cohort 1: MOv19-BBz CAR T Cells Without Chemo n=3 Participants 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.	Cohort 2: MOv19-BBz CAR T Cells After Chemo n=3 Participants 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.	Cohort 3: MOv19-BBz CAR T Cells After Chemo n=3 Participants 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.	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.
Overall Survival (OS)	187 Days Interval 184.0 to 248.0	163 Days Interval 85.0 to 975.0	136 Days Interval 18.0 to 332.0	—

Adverse Events

Cohort 1: MOv19-BBz CAR T Cells Without Chemo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort 2: MOv19-BBz CAR T Cells After Chemo

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 3: MOv19-BBz CAR T Cells After Chemo

Serious events: 4 serious events

Other events: 4 other events

Deaths: 3 deaths

Cohort-1: Without Chemo;Only if Dose De-escalation Required

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: MOv19-BBz CAR T Cells Without Chemo n=3 participants at risk 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.	Cohort 2: MOv19-BBz CAR T Cells After Chemo n=3 participants at risk 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.	Cohort 3: MOv19-BBz CAR T Cells After Chemo n=5 participants at risk 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.	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.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	20.0% 1/5 • Number of events 1 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	— 0/0 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	33.3% 1/3 • Number of events 1 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	20.0% 1/5 • Number of events 1 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	— 0/0 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	20.0% 1/5 • Number of events 1 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	— 0/0 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	33.3% 1/3 • Number of events 1 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	60.0% 3/5 • Number of events 3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	— 0/0 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.
Infections and infestations Sepsis	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	20.0% 1/5 • Number of events 1 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	— 0/0 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.
Investigations Platelet count decreased	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	20.0% 1/5 • Number of events 1 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	— 0/0 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	20.0% 1/5 • Number of events 1 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	— 0/0 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	33.3% 1/3 • Number of events 1 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	0.00% 0/5 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	— 0/0 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	33.3% 1/3 • Number of events 1 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	0.00% 0/5 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	— 0/0 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other (Acute myeloid leukemia)	33.3% 1/3 • Number of events 1 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	0.00% 0/3 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	0.00% 0/5 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.	— 0/0 • Up to 34 months For this study, collection of adverse events will begin at the time of apheresis and will continue until the subject is off-study. For subjects who do not undergo apheresis on this study (i.e. historical apheresis product available), adverse event reporting period will begin at the time of CAR T cell infusion (Cohorts 1 and -1) or at the start of lymphodepleting chemotherapy (Cohorts 2 and 3). Collection of adverse events will continue until the subject is off-study.

Other adverse events

Additional Information

Regulatory Lead

University of Pennsylvania

Phone: 215-662-4484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place