Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer
This is a phase I dose escalation study of CAN-2409 plus prodrug in patients with non-small cell lung cancer (NSCLC). The primary clinical objective of the study is to evaluate the safety of CAN-2409 plus prodrug when combined with standard surgery for NSCLC. The primary scientific objective is to determine the immunologic changes induced by CAN-2409 plus prodrug.
Checked against the public recordLast updated Jul 11, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Candel Therapeutics, Inc.
- Interventions being studied
- Biological: CAN-2409 + valacyclovir
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Pathologically documented non-small cell carcinoma (cytology or histology) that is accessible via standard-of-care staging procedures: (1) EBUS or (2) surgical approaches (eg mediastinoscopy, mediastinotomy or VATS). * Resectable with negative lymph nodes based on imaging with histologic confirmation at time of the staging procedure prior to AdV-tk injection * The tumor must be 4cm or greater in diameter based on imaging * ECOG Performance status of 0 or 1. * Granulocyte count (ANC) ≥ 1,000/mm3 * Peripheral lymphocyte count ≥ 500/mm3 * Hemoglobin ≥ 9 g/dl * Platelets ≥ 100,000/mm3 * Total bilirubin ≤ 1.5 x upper limit of normal * SGOT (AST) ≤ 3x upper limit of normal * Serum creatinine \< 2mg/dl * Calculated creatinine clearance \> 30ml/min * Patients must give study specific informed consent prior to enrollment Exclusion Criteria: * Radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic agents within 4 weeks prior to infusion of the vector. * Known immunodeficiency such as HIV infection * Active liver disease, including known cirrhosis or active hepatitis * Use of systemic corticosteroids (\>10 mg prednisone per day or equivalent) or other systemic immunosuppressive drugs * Patient is pregnant or breast-feeding. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy. Subjects must use acceptable means of birth control until 30 days after the vector injection. * Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependence, significant chronic obstructive pulmonary disease (COPD), end-stage liver or renal disease. COPD will be considered significant if disease limits activities of daily living, results in the inability to walk up 1 flight of stair, or requires home oxygen. * Presence of known untreated brain metastases. * Prior bone marrow transplants (including stem cells) except autologous stem cell transplant without immunosuppression is NOT considered an exclusion. * Known sensitivity or allergic reactions to valacyclovir
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of PennsylvaniaPhiladelphia, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 11, 2025. Always confirm current availability with the study team.