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Virus Therapy
Gene-Mediated Immunotherapy for Lung Cancer
Phase 1
Waitlist Available
Research Sponsored by Candel Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Resectable with negative lymph nodes based on imaging with histologic confirmation at time of the staging procedure prior to AdV-tk injection
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)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer treatment, which uses a person's own immune cells to fight their cancer. The goal is to see if it is safe and if it causes any changes in the immune system.
Who is the study for?
This trial is for adults with non-small cell lung cancer that can be removed by surgery, have no lymph node involvement, and a tumor size of at least 4cm. Participants should be relatively healthy (ECOG status 0 or 1) and not on strong immunosuppressants or have had recent chemotherapy. Pregnant women and those with severe chronic diseases or known allergies to the study medication are excluded.
What is being tested?
The trial tests CAN-2409 plus valacyclovir in patients undergoing standard surgery for non-small cell lung cancer. It aims to find the safest dose while observing how this combination affects the body's immune response against cancer cells.
What are the potential side effects?
Potential side effects may include reactions related to gene therapy such as flu-like symptoms, pain at injection site, fatigue, and possible allergic reactions to valacyclovir including skin rash and other signs of intolerance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is operable and my lymph nodes are cancer-free, confirmed by tests before AdV-tk injection.
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My lung cancer diagnosis was confirmed through standard tests.
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I am fully active or can carry out light work.
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My kidneys are functioning well enough to clear waste.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active liver condition, such as cirrhosis or hepatitis.
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I am not taking high doses of steroids or other drugs that weaken my immune system.
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I do not have any severe illnesses like heart problems, severe lung issues, or end-stage liver or kidney disease.
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I have brain metastases that have not been treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Study ArmExperimental Treatment1 Intervention
CAN-2409 + valacyclovir
Find a Location
Who is running the clinical trial?
Candel Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
1,261 Total Patients Enrolled
University of PennsylvaniaOTHER
2,072 Previous Clinical Trials
42,713,974 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a weakened immune system, like from HIV infection.I have an active liver condition, such as cirrhosis or hepatitis.I haven't had radiotherapy or cancer drugs in the last 4 weeks.Your hemoglobin level should be 9 grams per deciliter or higher.Your bilirubin levels should be within a certain range.Your SGOT (AST) levels should be within three times the upper limit of normal.I am not taking high doses of steroids or other drugs that weaken my immune system.I do not have any severe illnesses like heart problems, severe lung issues, or end-stage liver or kidney disease.I have brain metastases that have not been treated.I have had a bone marrow transplant, but it was with my own stem cells and without immunosuppression.My cancer is operable and my lymph nodes are cancer-free, confirmed by tests before AdV-tk injection.My lung cancer diagnosis was confirmed through standard tests.You must have a white blood cell count of at least 1,000 per cubic millimeter.The tumor must be at least 4 centimeters wide when checked with imaging.You have enough white blood cells in your body.I am not pregnant or breastfeeding and will use birth control during and after treatment.Your creatinine level in the blood is less than 2mg/dl.I am fully active or can carry out light work.You have enough platelets in your blood, at least 100,000 per cubic millimeter.My kidneys are functioning well enough to clear waste.You have had allergic reactions to valacyclovir in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Study Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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