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New treatment option for Metastatic Non Small Cell Lung Cancer
Official title MOv19-BBz CAR T Cells in FRa+ Cancers
ClinicalTrials.gov ID: NCT07116057
What this study is testing
What is MOv19-BBz CAR T cells?
MOv19-BBz CAR T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed informed consent form
- Documentation of tumor FRa expression by IHC at the Hospital of the University of Pennsylvania (≥ 10% of tumor cells). people must have archived...
- Disease-specific criteria: a. NSCLC Patients: i. Metastatic or recurrent lung adenocarcinoma with cytologically or pathologically confirmed malignant...
- 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...
You likely can't join 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...
- 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...
- Patients with radiographic evidence of significant pleural effusion that is not readily amenable to minimally invasive drainage.
See the full eligibility criteria
- Signed informed consent form
- Documentation of tumor FRa expression by IHC at the Hospital of the University of Pennsylvania (≥ 10% of tumor cells). people 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...
- 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 \ 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
- people must be a possible clinical candidate for standard of care treatment with a commercial checkpoint inhibitor, as per physician-investigator assessment.
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.