Actively Recruiting
MOv19-BBz CAR T Cells in FRa+ Cancers
Led by University of Pennsylvania · Updated on 2025-10-10
10
Participants Needed
1
Research Sites
781 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MOv19-BBz CAR T Cells in FRa+ Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Tumor shows folate receptor alpha (FRa) expression in at least 10% of tumor cells by immunohistochemistry
- Metastatic or recurrent lung adenocarcinoma with confirmed malignant pleural effusion
- Failure of at least one prior standard therapy for advanced disease
- Evidence of active disease by RECIST 1.1 criteria
- Patients with treated, asymptomatic CNS metastases off steroids, no progression on MRI, no leptomeningeal disease or cord compression
- Adequate organ function including creatinine 4 1.5 mg/dl or creatinine clearance 5 30 cc/min, no dialysis
- Liver enzymes ALT/AST 3 times upper limit normal
- Total bilirubin 1.5 mg/dl or 3.0 mg/dl if Gilbert's syndrome
- Pulmonary reserve with less than grade 1 dyspnea and oxygen saturation above 92% on room air
- Left ventricular ejection fraction 40% confirmed by echo or MUGA
- Male or female age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Suitable candidate for standard care checkpoint inhibitor treatment as assessed by physician
You will not qualify if you...
- Clinically significant pleural effusion that cannot be drained with standard methods
- Significant lung disease with extensive lymphangitic involvement or bronchial wall thickening, or extensive bilateral metastatic burden
- Active radiation pneumonitis
- Underlying interstitial lung disease or unresolved drug toxicity in lungs
- Significant pleural effusion not amenable to minimally invasive drainage
- Active hepatitis B or C infection
- Any other active, uncontrolled infection
- Class III or IV cardiovascular disability by New York Heart Association classification
- Active invasive cancer other than the study cancer within 2 years prior to eligibility (non-invasive cancers treated curatively allowed)
- Dependence on systemic steroids or immunosuppressants
- Pregnant or nursing women; agreement to use birth control if of reproductive potential
- Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to 10 mg or more prednisone daily; autoimmune neurologic diseases excluded
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, Dextran 40)
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Abramson Cancer Center Clinical Trials Service
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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