MOv19-BBz CAR T Cells in FRa+ Cancers (NCT07116057) | Clinical Trial Compass
RecruitingPhase 1
MOv19-BBz CAR T Cells in FRa+ Cancers
United States10 participantsStarted 2025-10-07
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused primarily on safety, what does that mean for what we actually know so far about whether this CAR T cell therapy works against my non-small cell lung cancer?
2The trial is specifically looking at treatment-limiting toxicities — what kinds of serious side effects have been seen with CAR T cell therapies like this one, and how would we manage them if they happened to me?
3My cancer needs to test positive for a protein called folate receptor alpha (FRα) to be relevant to this trial — has my tumor already been tested for this, or would that need to happen before we could even consider it?
4Given that this is a first-in-human type of safety study, how does the level of uncertainty here compare to standard treatment options I might still have available for metastatic non-small cell lung cancer?
5If I were to discuss enrolling in this trial, what would the treatment schedule and monitoring visits actually look like, and how might that affect my day-to-day life and other ongoing care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events as assessed by CTCAE V5.0
Timeframe: Up to 15 years post-MOv19-BBz CAR T cell administration
2
Occurrence of treatment-limiting toxicities (TLTs)
Timeframe: 28 days post-MOv19-BBz CAR T cell administration
. No evidence of leptomeningeal disease or cord compression
Exclusion criteria
. 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.