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T-Cell Therapy for Cancer

Phase 2

Waitlist Available

Led By Nicholas D Klemen, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Resected pancreas ductal adenocarcinoma (PDAC)

History of detectable circulating tumor DNA (ctDNA) after resection/local treatment of all known disease for stage I-III PDAC

Must not have

Active or chronic infections requiring anti-microbial, anti-fungal, or anti-viral treatment

History of major organ autoimmune disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until 6 months after the last dose of study agents

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a therapy using modified T-cells to prevent or delay the return of gastrointestinal (GI) cancer after standard treatment. Participants with specific gene mutations and HLA types will be divided

Who is the study for?

This trial is for adults aged 18-72 with GI cancer that's been treated but might be spreading, as shown by blood tests. They need specific gene mutations (KRAS or TP53) and HLA types. People can't join if they don't meet the age requirement, lack the necessary genetic profile, or have visible cancer on scans.

What is being tested?

The study compares two groups: one receives T-cell therapy where their own immune cells are modified in a lab to target cancer cells; another group doesn’t get this treatment. Participants are randomly assigned to either group and followed up for years to see if the therapy prevents cancer from returning.

What are the potential side effects?

Potential side effects may include reactions related to chemotherapy like nausea, hair loss, fatigue; immune responses due to modified T-cells such as fever or flu-like symptoms; and infusion-related reactions from receiving cells through a vein.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery to remove pancreatic cancer.

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I have had pancreatic cancer cells found in my blood after treatment.

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My stage IV cancer was treated with chemotherapy and then surgically removed.

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My CA19-9 levels were high at diagnosis and after surgery for early-stage pancreatic cancer.

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My stage IV colorectal cancer spread to liver, lung, or lymph nodes but was fully treated locally.

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I had surgery to remove cancer in my stomach, liver, bile ducts, duodenum, small intestine, or colon.

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My cancer has specific genetic changes.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am between 18 and 72 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on treatment for a long-term infection.

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I have a history of autoimmune disease affecting major organs.

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I do not have any uncontrolled illnesses.

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I have had heart surgery or symptoms of reduced blood flow to my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks then every 3 months x 3, every 6 months after that until progression or 5 years since randomization.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks then every 3 months x 3, every 6 months after that until progression or 5 years since randomization.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks then every 3 months x 3, every 6 months after that until progression or 5 years since randomization. for reporting.