MOv19-BBz CAR T Cells in FRa+ Cancers

Recruiting now · Phase 1

Conditions studied: Metastatic Non Small Cell Lung Cancer, Recurrent Lung Non-Small Cell Carcinoma

In brief

This is a Phase I open-label clinical trial to assess the safety, feasibility, and preliminary efficacy of intrapleural administration of MOv19-BBz CAR T cells in patients with FRa+ cancers. This study will be initiated in patients with metastatic or recurrent non-small cell lung cancer (NSCLC) only. Subjects will receive a single dose of MOv19-BBz CAR T cells via intrapleural infusion following lymphodepleting chemotherapy. Subjects without an existing intra-pleural catheter will have a temporary pleural catheter placed for the study. Subjects may initiate treatment with commercial checkpoint inhibitors per routine care beginning at least 28 days after receiving MOv19-BBz CAR T cells.

Key facts

Study ID: NCT07116057
Run by: University of Pennsylvania
People needed: 10
Starts: 2025-10-07
Expected to finish: 2040-10-01
Last updated by the study team: 2026-06-18

Who can join

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

You may qualify if…

Signed informed consent form
Documentation of tumor FRa expression by IHC at the Hospital of the University of Pennsylvania (≥ 10% of tumor cells). Subjects must have archived tumor tissue available.
Disease-specific criteria:
a. NSCLC Patients: i. Metastatic or recurrent lung adenocarcinoma with cytologically or pathologically confirmed malignant pleural effusion.
ii. Failure of at least one prior line of standard of care therapy for advanced stage disease.
Patients must have evidence of active disease as defined by RECIST 1.1 criteria
Patients with asymptomatic CNS metastases that have been treated (and are off steroids for the treatment of CNS disease) are allowed. They must meet the following criteria
No concurrent treatment for the CNS disease
No progression of CNS metastasis on MRI at screening
No evidence of leptomeningeal disease or cord compression
Adequate organ function deﬁned as:
Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 30 cc/min; Patient must not be on dialysis
ALT/AST ≤ 3x upper limit of normal range
Serum total bilirubin ≤ 1.5 mg/dl, unless the subject has Gilbert's syndrome (if so, serum total bilirubin must be ≤ 3.0 mg/dl)
Must have a minimum level of pulmonary reserve deﬁned as < Grade 1 dyspnea and pulse oxygen > 92% on room air
Left Ventricle Ejection Fraction (LVEF) ≥ 40% conﬁrmed by ECHO or MUGA
Male or female age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status that is either 0 or 1
Subjects must be a possible clinical candidate for standard of care treatment with a commercial checkpoint inhibitor, as per physician-investigator assessment.

You may not qualify if…

Any clinically signiﬁcant pleural eﬀusion that cannot be drained with standard approaches.
Patients with signiﬁcant lung disease as follows:
Patients with radiographic evidence of greater than lobar lymphangitic pulmonary involvement, greater than lobar bronchial wall thickening suggestive of peribronchial lymphatic disease extension, and/or evidence of extensive bilateral parenchymal metastatic burden.Note: "Greater than lobar" = "in more than 1 lobe".
Patients with radiographic and/or clinical evidence of active radiation pneumonitis.
Patients with radiographic evidence of underlying interstitial lung disease, including evidence of unresolved drug toxicity from any agent (e.g. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc.).
Patients with radiographic evidence of signiﬁcant pleural effusion that is not readily amenable to minimally invasive drainage.
Active hepatitis B or hepatitis C infection
Any other active, uncontrolled infection
Class III/IV cardiovascular disability according to the New York Heart Association Classiﬁcation
Active invasive cancer, other than the proposed cancer included in this protocol, within 2 years prior to eligibility confirmation by a physician-investigator. [Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible].
Dependence on systemic steroids or immunosuppressant medications.
Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods
Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone daily. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)

Where it is running

University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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