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

Stopped early · Phase 1

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

In brief

Phase I study to establish safety and feasibility of intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy

Key facts

Study ID

NCT03585764

Run by

University of Pennsylvania

People needed

46

Starts

2018-10-24

Expected to finish

2024-03-26

Last updated by the study team

2025-03-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• No concurrent treatment for the CNS disease
• No progression of CNS metastasis on brain MRI at screening
• 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.

You may not qualify if…

• 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.

Where it is running

• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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