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AFPᶜ³³²T Cells for Advanced Liver Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I had major surgery over 4 weeks ago and have recovered from it.I have a severe autoimmune disease but not autoimmune hepatitis.I am between 18 and 75 years old and agree to participate in the study.My organs are functioning well.I used an experimental vaccine 2 months ago without improvement in my cancer.I have lasting side effects from cancer treatment, but they are not severe.I have tested positive for HTLV 1 or 2.I haven't had chemotherapy or certain radiation therapies in the specified time before starting lymphodepleting chemotherapy.I have not had any cancer other than liver or AFP-related cancer in the last 3 years.I took Sorafenib, Regorafenib, or Lenvatinib within the last week before starting chemotherapy to reduce my white blood cells.I took Cabozantinib less than 2 weeks before starting lymphodepleting chemotherapy.My liver cancer can't be treated with surgery or transplant. I may have treatment targeting specific areas after joining.My cancer has worsened despite treatment, or I cannot tolerate or refuse standard treatments.My blood test shows AFP levels of 100ng/mL or higher and my liver is mostly free of AFP.I have a specific genetic marker related to my immune system.My cancer has spread to my brain.I took Cabozantinib less than 2 weeks before my leukapheresis.I haven't taken any immune-weakening drugs in the last 2 weeks, except for inhaled or topical steroids.I had radiation therapy for bone or soft tissue within the last 4 weeks.I have received immunotherapy for cancer within the last 4 weeks.I have the A*02:01 gene variant.My liver cancer shows high AFP levels in both tumor and blood tests.I am fully active or can carry out light work.I have had significant bleeding in the last 3 months.I need blood-thinning medication from the start of my cell-depleting treatment until my blood platelet count returns to normal.I have hepatitis B but am not on antiviral treatment.My ECG shows a significant abnormality or my QTc interval is longer than normal.I haven't had any serious infections except for a cold or simple bladder infection in the last 3 months.My liver functions well enough for treatment.I have had gene therapy with an integrated vector before.I have had a liver transplant.I have not had chemotherapy, immune, or biological therapy in the last 3 weeks.I have noticeable fluid buildup in my abdomen that needs medication.I have a liver-related brain condition that needs medication.I haven't taken any immune-weakening drugs, except inhalers or creams, in the last 2 weeks.I have taken Sorafenib, Regorafenib, or Lenvatinib within the last week.
- Group 1: Autologous genetically modified AFPᶜ³³²T cells
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are persons younger than 60 years of age qualified for this experimental research?
"This trial seeks participants aged 18 to 75."
What potential adverse events have been observed with Autologous genetically modified AFPᶜ³³²T cell therapy?
"The safety of Autologous genetically modified AFPᶜ³³²T cells is estimated to be a 1 due to the fact that this trial is in its early stages, thus providing limited evidence for efficacy and an even smaller amount of data on safety."
Are there any opportunities to join this experiment currently available?
"Clinicaltrials.gov information indicates that this clinical trial, which was made available on May 8th 2017 and last updated August 26th 2022, is no longer accepting applicants; however, there are 774 other studies actively recruiting patients at the moment."
Do I meet the qualifications to join this medical experiment?
"This investigation is enrolling 45 individuals with hepatocellular cancer aged 18-75. To qualify, applicants must fulfill the following conditions: having histologically confirmed HCC that cannot be treated through transplant or resection; undergoing loco-regional therapy after enrollment but not at lymphodepletion time; possessing a life expectancy of greater than 4 months; attaining a Child-Pugh score of 6 or less; obtaining an Eastern Cooperative Oncology Group (ECOG) 0 - 1 rating and adequate organ function as defined in the protocol; presenting progressive disease resulting from standard care systemic therapy prior to lymphodepletion"
How many healthcare providers are administering this trial?
"Currently, 11 medical centres are registering patients for this trial. These sites span from Phoenix to Miami, and many other locations in between. It is recommended that you select the closest centre available to minimize travel obligations if accepted into the study."
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