Phase I Clinical Trial of Autologous Folate Receptor-Alpha Redirected T Cells in Patients With FRa+ Cancers

Status: Recruiting
Location: See location...
Intervention Type: Biological, Device, Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

• 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.

• 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 \< 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.

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Abramson Cancer Center Clinical Trials Service
PMCancerResearch@pennmedicine.upenn.edu
215-349-8245
Time Frame
Start Date: 2025-10-07
Estimated Completion Date: 2040-10
Participants
Target number of participants: 10
Treatments
Experimental: Dose Level 1 (DL1)
single dose of 5x10(7) MOv19-BBz CAR T cells administered via intrapleural infusion following lymphodepleting chemotherapy
Experimental: Dose Level -1 (DL-1)
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.
Sponsors
Leads: University of Pennsylvania
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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