10 Participants Needed

MOv19-BBz CAR T Cells for Lung Cancer

AC
Overseen ByAbramson Cancer Center Clinical Trials Service
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new CAR T cell therapy, a type of immune cell treatment, to determine its safety and effectiveness for individuals with a specific type of lung cancer that has spread or recurred after treatment. The treatment involves administering these special cells directly into the chest area after initial chemotherapy. Individuals with non-small cell lung cancer and fluid around the lungs due to cancer, who have not found success with other treatments, might be suitable candidates for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot be on systemic steroids or immunosuppressant medications, and you must not have unresolved drug toxicity from any agent. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that MOv19-BBz CAR T cells are likely to be safe for humans?

Research shows that MOv19-BBz CAR T cells are being tested for safety in people with certain lung cancers. This treatment uses specially modified immune cells to attack cancer cells.

As a Phase 1 trial, this is the first time the treatment is tested in humans, so detailed safety information is not yet available. Early studies in labs and animals showed promise, but human responses can differ.

Phase 1 trials typically aim to find the right dose and observe how people react to the treatment. Possible side effects might include reactions to the infusion or changes in blood cell levels. The trial will help identify any side effects and their frequency.

Prospective participants should discuss potential risks and benefits with their doctor before joining the trial.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lung cancer, which typically involve chemotherapy, radiation, or surgery, MOv19-BBz CAR T cells offer a novel approach by using genetically engineered cells that specifically target cancer cells. Researchers are excited about this treatment because it harnesses the body's own immune system to attack the cancer, potentially leading to more precise and effective treatment. Additionally, these CAR T cells are delivered directly into the space around the lungs (intrapleural infusion), which may increase their effectiveness against lung tumors. This targeted approach could mean fewer side effects compared to traditional therapies, marking a significant advancement in lung cancer treatment.

What evidence suggests that MOv19-BBz CAR T cells might be an effective treatment for lung cancer?

Studies have shown that CAR T-cell therapies can lead to high remission rates, quickly destroy tumors, and provide long-lasting benefits for some patients. This trial tests MOv19-BBz CAR T cells as a treatment for FRa+ cancers, including certain types of non-small cell lung cancer (NSCLC). The treatment uses modified immune cells to better recognize and attack cancer cells. Early studies suggest it could be safe and effective for treating advanced or returning NSCLC, especially when the cancer cells have the FRalpha protein. While more research is needed, these initial findings are promising for those with FRa+ cancers.12356

Who Is on the Research Team?

AH

Andrew Haas, MD, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for patients with metastatic or recurrent non-small cell lung cancer (NSCLC) who express FRa. They must be able to receive intrapleural MOv19-BBz CAR T cells after lymphodepleting chemotherapy. A temporary pleural catheter will be placed if they don't already have one.

Inclusion Criteria

Signed informed consent form
My tumor shows FRa expression and I have tissue samples available.
I have treated brain metastases, am not on steroids, and have no spinal or leptomeningeal disease.
See 3 more

Exclusion Criteria

Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods
I rely on steroids or immunosuppressant drugs.
I have a serious fluid buildup in my chest that can't be drained normally.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy prior to CAR T cell infusion

1 week

Treatment

Participants receive a single dose of MOv19-BBz CAR T cells via intrapleural infusion

1 day
1 visit (in-person)

Initial Follow-up

Participants are monitored for treatment-limiting toxicities and adverse events

4 weeks
Weekly visits (in-person)

Long-term Follow-up

Participants are monitored for safety and effectiveness, including overall survival and progression-free survival

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

  • MOv19-BBz CAR T cells
Trial Overview The study tests the safety and effectiveness of MOv19-BBz CAR T cells given through the chest cavity, following a pre-treatment with Cyclophosphamide/Fludarabine to reduce immune cells. It's an early-phase trial where all participants get this new therapy.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Dose Level 1 (DL1)Experimental Treatment3 Interventions
Group II: Dose Level -1 (DL-1)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

NCT07116057 | MOv19-BBz CAR T Cells in FRa+ CancersThis is a Phase I open-label clinical trial to assess the safety, feasibility, and preliminary efficacy of intrapleural administration of MOv19-BBz CAR T ...
MOv19-BBz CAR T Cells for the Treatment of Folate ...Giving MOv19-BBz CAR T cell therapy may be safe, tolerable, and/or effective in treating patients with metastatic or recurrent FRalpha positive non-small cell ...
MOv19-BBz CAR T Cells in FRa+ CancersThis study will be initiated in patients with metastatic or recurrent non-small cell lung cancer (NSCLC) only.
MOv19-BBz CAR T Cells for Lung CancerThis 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 ...
Current advances and challenges in CAR T-Cell therapy for ...Because of its high remission rates, rapid tumor eradication, and long-lasting response in patients, CAR T-cell therapy has shown great ...
CAR T cell therapy in solid tumors: A review of current clinical ...This review article highlights currently active clinical trials and a few pertinent preclinical studies involving CAR T cell therapy in solid tumors.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security