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CAR T-cell Therapy

AFPᶜ³³²T Cells for Advanced Liver Cancer

Phase 1

Waitlist Available

Led By Richard S Finn, MD

Research Sponsored by Adaptimmune

Eligibility Criteria Checklist

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

Must have

Progressive disease following or intolerant of or refuses standard of care systemic therapy prior to lymphodepletion

Group 4 (other AFP expressing tumor types) Subjects will be eligible for enrollment if they meet either one of these AFP expression criteria: Serum AFP levels of ≥100ng/mL and their non-cancerous liver tissue (if applicable) has ≤5% cells stained for AFP at any intensity by immunohistochemistry

Must not have

Underwent major surgery within 4 weeks prior to lymphodepletion; subjects should have been fully recovered from any surgical related toxicities

Have positive serology for HTLV 1 or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for men and women between 18 and 75 years of age who have advanced liver cancer which has grown or returned after being treated or another AFP expressing tumor. The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.

Who is the study for?

This trial is for adults aged 18-75 with advanced liver cancer or other AFP expressing tumors, who have not responded to standard treatments or cannot tolerate them. Participants must have a life expectancy over 4 months, measurable disease progression, and specific levels of alpha-fetoprotein (AFP) in their blood and tumor cells. They should be relatively healthy otherwise, with adequate organ function and no severe heart or psychiatric conditions.

What is being tested?

The study tests genetically modified T cells targeting the AFP protein on cancer cells. Patients' own T cells are taken and engineered in a lab to fight the cancer, then reinfused after chemotherapy. The trial aims to determine the safest dose level of these modified T cells and observe their effects on liver cancer or other AFP expressing tumors over time.

What are the potential side effects?

Potential side effects may include reactions related to immune cell infusion such as fever, chills, fatigue; complications from chemotherapy like nausea; increased risk of infection; organ inflammation due to an immune response against normal tissue; plus any unforeseen risks associated with gene therapy.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has worsened despite treatment, or I cannot tolerate or refuse standard treatments.

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My blood test shows AFP levels of 100ng/mL or higher and my liver is mostly free of AFP.

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I have the A*02:01 gene variant.

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My liver cancer shows high AFP levels in both tumor and blood tests.

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I am fully active or can carry out light work.

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My liver functions well enough for treatment.

Exclusion Criteria

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

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I had major surgery over 4 weeks ago and have recovered from it.

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I have tested positive for HTLV 1 or 2.

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I haven't had chemotherapy or certain radiation therapies in the specified time before starting lymphodepleting chemotherapy.

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I have not had any cancer other than liver or AFP-related cancer in the last 3 years.

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I took Sorafenib, Regorafenib, or Lenvatinib within the last week before starting chemotherapy to reduce my white blood cells.

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I have a specific genetic marker related to my immune system.

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My cancer has spread to my brain.

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I have received immunotherapy for cancer within the last 4 weeks.

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I have had significant bleeding in the last 3 months.

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I need blood-thinning medication from the start of my cell-depleting treatment until my blood platelet count returns to normal.

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I have hepatitis B but am not on antiviral treatment.

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My ECG shows a significant abnormality or my QTc interval is longer than normal.

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I have had gene therapy with an integrated vector before.

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I have had a liver transplant.

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I have not had chemotherapy, immune, or biological therapy in the last 3 weeks.

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I have noticeable fluid buildup in my abdomen that needs medication.

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I have a liver-related brain condition that needs medication.

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I have taken Sorafenib, Regorafenib, or Lenvatinib within the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of subjects with dose-limiting toxicity (DLT) and adverse events (AEs) and determination of optimally tolerated dose range, including serious adverse events (SAE).

Secondary study objectives

Interval between the date of first T cell infusion and date of disease progression or death due to any cause

Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause

Interval between the date of first T cell infusion dose and first documented evidence of CR or PR

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