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Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CAN-2409 + valacyclovir

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring aglatimagene besadenovec, CAN-2409, immunotherapy, GMCI, AdV-tk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Arm

Arm Description

CAN-2409 + valacyclovir

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events

Secondary Outcome Measures

Progression free survival (PFS)

Overall survival (OS)

Full Information

NCT ID

NCT03131037

First Posted

April 24, 2017

Last Updated

August 23, 2023

Sponsor

Candel Therapeutics, Inc.

Collaborators

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT03131037

Brief Title

Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer

Official Title

Intratumoral Gene Mediated Cytotoxic Immunotherapy (GMCI) For Resectable Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 4, 2017 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Candel Therapeutics, Inc.

Collaborators

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

The purpose of this open-label, dose escalation clinical trial is to investigate the safety of CAN-2409 (aglatimagene besadenovec) plus prodrug prior to surgery in patients with NSCLC. CAN-2409 is a viral immunotherapy approach which utilizes intratumoral administration to selectively induce tumor cell death and elicit both an innate and an adaptive systemic anti-tumor immune response against the injected tumor and uninjected metastases. Local delivery enables these effects while aiming to minimize systemic toxicity. Standard of care surgical resection will be performed about 3 weeks after the CAN-2409 injection. Chemotherapy and/or radiation may begin 6-8 weeks after resection surgery. Choice of chemotherapy depends on the treating oncologist. CAN-2409 (aglatimagene besadenovec) was previously known as AdV-tk, and the combination of CAN-2409 plus prodrug was previously known as GMCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

aglatimagene besadenovec, CAN-2409, immunotherapy, GMCI, AdV-tk

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Open Label

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Arm

Arm Type

Experimental

Arm Description

CAN-2409 + valacyclovir

Intervention Type

Biological

Intervention Name(s)

CAN-2409 + valacyclovir

Intervention Description

CAN-2409 will be administered intratumorally followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each injection.

Primary Outcome Measure Information:

Title

Incidence of treatment emergent adverse events

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Progression free survival (PFS)

Time Frame

5 years

Title

Overall survival (OS)

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33160076

Citation

Predina JD, Haas AR, Martinez M, O'Brien S, Moon EK, Woodruff P, Stadanlick J, Corbett C, Frenzel-Sulyok L, Bryski MG, Eruslanov E, Deshpande C, Langer C, Aguilar LK, Guzik BW, Manzanera AG, Aguilar-Cordova E, Singhal S, Albelda SM. Neoadjuvant Gene-Mediated Cytotoxic Immunotherapy for Non-Small-Cell Lung Cancer: Safety and Immunologic Activity. Mol Ther. 2021 Feb 3;29(2):658-670. doi: 10.1016/j.ymthe.2020.11.001. Epub 2020 Nov 5.

Results Reference

result

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/33160076/

Description

Neoadjuvant Gene-Mediated Cytotoxic Immunotherapy for Non-Small-Cell Lung Cancer: Safety and Immunologic Activity

Learn more about this trial

Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer

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