AFPᶜ³³²T Cells for Advanced Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of a new treatment using genetically modified T cells to target liver cancer that has returned or grown after treatment, or other similar tumors. Researchers take T cells, a type of immune cell, from the patient, modify them in a lab to better fight cancer, and then reintroduce them into the body. This study suits those whose liver cancer has progressed despite other treatments and who have specific blood markers related to the cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before participating. You must stop cytotoxic chemotherapy, immune therapy, and biological therapy 3 weeks before leukapheresis, and corticosteroids or other immunosuppressive therapy 2 weeks before. Specific cancer drugs like Sorafenib must be stopped 1 week before, and Cabozantinib 2 weeks before. Discuss any other medications with the study physician.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that treatments like AFPᶜ³³²T cells, which target the protein alpha-fetoprotein (AFP) in liver cancer, have promising safety results. In studies with similar treatments, patients generally tolerated them well. For instance, no significant liver damage occurred in patients who received up to 100 million modified cells. This indicates the treatment does not cause major harm to the liver, which is crucial since the liver is the primary organ affected by this cancer.
Additionally, cell-based immune therapies are gaining popularity for their safety and effectiveness in treating various cancers. These therapies use the body's own immune cells, reprogrammed to attack cancer cells, potentially leading to fewer severe side effects compared to traditional cancer treatments.
While more research is needed to fully understand the safety of AFPᶜ³³²T cells, early results are encouraging. Researchers will closely monitor trial participants for any side effects, ensuring that any potential issues are quickly identified and addressed.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for advanced liver cancer, which typically include surgery, chemotherapy, or targeted therapies like sorafenib, AFPᶜ³³²T cells offer a unique approach by using a patient's own immune cells. These autologous T cells are genetically modified to specifically target and attack cancer cells expressing the AFP protein, which is often found in liver cancer. Researchers are excited about this treatment because it harnesses the body's natural defenses, potentially offering a more precise and personalized method to combat the cancer with fewer side effects. This innovative approach could represent a significant shift in how we treat liver cancer, providing hope for more effective interventions.
What evidence suggests that AFPᶜ³³²T cells might be an effective treatment for advanced liver cancer?
Research has shown that specially modified T cells, such as AFPᶜ³³²T cells, hold potential for treating advanced liver cancer. In this trial, participants will receive autologous genetically modified AFPᶜ³³²T cells. Early studies found that similar T cell therapies effectively fight cancer by targeting specific proteins on cancer cells. In this case, the T cells are designed to attack cells with alpha-fetoprotein (AFP), a protein often found in liver cancer. While this treatment is still under investigation, it builds on the success of other cell-based immune therapies, which help the body's immune system find and destroy cancer cells.12356
Who Is on the Research Team?
Richard S Finn, MD
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
T Cell Manufacturing
The subject's T cells are collected and sent to a laboratory to be genetically modified
Chemotherapy
Participants receive 3 days of chemotherapy prior to T cell infusion
Treatment
Participants receive an intravenous infusion of genetically modified T cells and are hospitalized for at least 1 week
Initial Follow-up
Participants are seen frequently by the Study Physician for monitoring after T cell infusion
Extended Follow-up
Participants are seen every three months for continued monitoring
Long-term Follow-up
Participants are monitored for safety and effectiveness every 6 months for the first 5 years, then annually for the next 10 years
What Are the Treatments Tested in This Trial?
Interventions
- AFPᶜ³³²T
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adaptimmune
Lead Sponsor