MOv19-BBz CAR T Cells in FRa+ Cancers
Phase I Clinical Trial of Autologous Folate Receptor-Alpha Redirected T Cells in Patients With FRa+ Cancers
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Subjects will receive a single dose of MOv19-BBz CAR T cells via intrapleural infusion following lymphodepleting chemotherapy."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This early study tests the safety of MOv19-BBz CAR T cells, a type of immune cell treatment, and whether they may help treat cancers with a marker called FRa. It will start with adults whose non-small cell lung cancer has spread or come back. Patients get chemotherapy first, then one dose of the cells through a tube into the space around the lungs.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and sign a study consent form.
- Have saved tumor tissue for testing at the University of Pennsylvania. At least 10% of tumor cells must have the FRa marker.
- Have lung adenocarcinoma, a type of non-small cell lung cancer, that has spread or come back, with confirmed cancer cells in fluid around the lungs.
- Have active cancer that meets the study’s measurement rules. At least one standard treatment for advanced cancer must have failed.
- If cancer has spread to the brain or spinal cord, it must have been treated, cause no symptoms, and show no growth on the screening MRI. No current treatment or steroids for it, cancer in its lining, or pressure on the spinal cord is allowed.
- Meet kidney, liver, lung, and heart test limits. You must not need dialysis, a treatment that filters the blood.
- Be fully active or able to walk and do light work despite limits on heavy activity.
- Be a possible candidate for a standard checkpoint inhibitor, a drug that helps the immune system fight cancer, based on the study doctor’s review.
Who can't join
- Have a large fluid buildup around the lungs that cannot be drained using standard, less invasive methods.
- Have certain serious lung problems, such as widespread cancer in the lungs, active lung swelling from radiation, or underlying lung damage, including damage from medicines that has not healed.
- Have active hepatitis B or C, or another active infection that is not controlled.
- Have severe heart disease that greatly limits activity or causes symptoms at rest.
- Have had another active cancer that grows into nearby tissue within the past 2 years. Some cancers that do not invade nearby tissue and were treated to cure them may be allowed.
- Depend on steroids or medicines that suppress the immune system. Also excluded are active autoimmune diseases needing treatment equal to at least 10 mg of prednisone daily, or autoimmune nerve diseases such as multiple sclerosis.
- Be pregnant or breastfeeding. People who could have children must agree to use acceptable birth control.
- Have an allergy to human serum albumin, DMSO, or Dextran 40, which are ingredients in the study treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Signed informed consent form 2. 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. 3. 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 of care therapy for advanced stage disease. 4. Patients must have evidence of active disease as defined by RECIST 1.1 criteria 5. 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 1. No concurrent treatment for the CNS disease 2. No progression of CNS metastasis on MRI at screening 3. No evidence of leptomeningeal disease or cord compression 6. Adequate organ function defined as: 1. Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 30 cc/min; Patient must not be on dialysis 2. ALT/AST ≤ 3x upper limit of normal range 3. 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) 4. Must have a minimum level of pulmonary reserve defined as \< Grade 1 dyspnea and pulse oxygen \> 92% on room air 5. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO or MUGA 7. Male or female age ≥ 18 years 8. Eastern Cooperative Oncology Group (ECOG) Performance Status that is either 0 or 1 9. Subjects must be a possible clinical candidate for standard of care treatment with a commercial checkpoint inhibitor, as per physician-investigator assessment. Exclusion Criteria: 1. Any clinically significant pleural effusion that cannot be drained with standard approaches. 2. Patients with significant lung disease as follows: 1. 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". 2. Patients with radiographic and/or clinical evidence of active radiation pneumonitis. 3. 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.). 4. Patients with radiographic evidence of significant pleural effusion that is not readily amenable to minimally invasive drainage. 3. Active hepatitis B or hepatitis C infection 4. Any other active, uncontrolled infection 5. Class III/IV cardiovascular disability according to the New York Heart Association Classification 6. Active invasive cancer, other than the proposed cancer included in this protocol, within 2 years prior to eligibility confirmation by a physician-investigator. \[Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible\]. 7. Dependence on systemic steroids or immunosuppressant medications. 8. Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods 9. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone daily. Patients with autoimmune neurologic diseases (such as MS) will be excluded. 10. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
Study sites (1)
PA
- University of Pennsylvania · Philadelphia, PA 19104Abramson Cancer Center Clinical Trials Service · Study contact · 215-349-8245 · PMCancerResearch@pennmedicine.upenn.eduMore trials in Philadelphia