Metastatic Non Small Cell Lung CancerPhase 1NCT07116057
MOv19-BBz CAR T Cells in FRa+ Cancers
A Phase 1 study testing MOv19-BBz CAR T cells, Cyclophosphamide/Fludarabine and FRa Expression Testing in people with Metastatic Non Small Cell Lung Cancer and Recurrent Lung Non-Small Cell Carcinoma, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non Small Cell Lung Cancer, Recurrent Lung Non-Small Cell Carcinoma
- What is being tested?
- MOv19-BBz CAR T cells, Cyclophosphamide/Fludarabine and FRa Expression Testing
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to Oct 2040
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- NSCLC Patients: i. Metastatic or recurrent lung adenocarcinoma with cytologically or pathologically confirmed malignant pleural effusion.
- 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
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abramson Cancer Center Clinical Trials Service contact
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Abramson Cancer Center Clinical Trials Service, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu
About this study
Official title: Phase I Clinical Trial of Autologous Folate Receptor-Alpha Redirected T Cells in Patients With FRa+ Cancers
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.
- Being tested
- MOv19-BBz CAR T cells, Cyclophosphamide/Fludarabine, FRa Expression Testing
- Keywords
- NSCLC, CAR T cells, FRa+, lung cancer, lung adenocarcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOv19-BBz CAR T cellsBiological
Autologous T cells engineered to express an extracellular single chain variable fragment (scFv) with FRa specificity.
Cyclophosphamide/FludarabineDrug
Cytotoxic chemotherapy agents used for lymphodepletion prior to MOv19-BBz CAR T cell administration.
FRa Expression TestingDevice
Laboratory Developed Test used to determine subject eligibility
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 (DL1) | Experimental | single dose of 5x10(7) MOv19-BBz CAR T cells administered via intrapleural infusion following lymphodepleting chemotherapy Receives: Biological: MOv19-BBz CAR T cells; Drug: Cyclophosphamide/Fludarabine; Device: FRa Expression Testing |
| Dose Level -1 (DL-1) | Experimental | 2.5x10(7) MOv19-BBz CAR T cells adminstered via intrapleural infusion, following lymphodepleting chemotherapy. This dose level will only be explored if ≥ 2 TLTs occur at any time in DL1. Receives: Biological: MOv19-BBz CAR T cells; Drug: Cyclophosphamide/Fludarabine; Device: FRa Expression Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events as assessed by CTCAE V5.0
Type, frequency, severity, and attribution of adverse events.
Measured: Up to 15 years post-MOv19-BBz CAR T cell administration
Occurrence of treatment-limiting toxicities (TLTs)
Unacceptable toxicity as defined by the protocol.
Measured: 28 days post-MOv19-BBz CAR T cell administration
Secondary outcomes (5)
Evaluate study feasibility
The proportion of enrolled subjects who are confirmed eligible and who receive study treatment as planned.
Measured: 6 months
Objective Response Rate (ORR)
Proportion of subjects with confirmed CR or PR per RECIST 1.1 criteria.
Measured: Up to 12 months following treatment with MOv19-BBz CAR T cells
Duration of Response (DOR)
Time from the date when confirmed CR or PR is first met, to the date of confirmed progressive disease, death due to any cause, or receipt of alternative anticancer therapy (excluding commercial immune checkpoint inhibitors as described by the study protocol); or it will be censored at the date of the last adequate assessment (whichever occurs first).
Measured: Up to 15 years following treatment with MOv19-BBz CAR T cells
Progression Free Survival (PFS)
Duration from study treatment to disease progression, receipt of alternative anti-cancer therapy, or death.
Measured: Up to 15 years following treatment with MOv19-BBz CAR T cells
Overall Survival (OS)
Duration of time from study treatment to the date of death, for any reason.
Measured: Up to 15 years following treatment with MOv19-BBz CAR T cell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start7 Oct 2025
- Primary completionOct 2040 (estimated)
- Study completionOct 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose Level -1 (DL-1) will only be explored if ≥ 2 Treatment Limited Toxicities occur at any time in DL1.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrew Haas, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116057
- Sponsor's protocol ID
- 858800 (UPCC #06525)
- Other IDs
- R01CA260902
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No