CAR T-cell Therapy for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CAR T-cell therapy for small cell neuroendocrine prostate cancer (SCNPC). The goal is to determine the best dose and assess its safety and effectiveness in treating cancer that has spread and cannot be surgically removed. The treatment modifies a patient's immune cells to better attack cancer cells. This trial may suit those with SCNPC that has spread, who have previously received platinum-based chemotherapy, and have L1CAM protein on their tumor. 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.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received certain therapies or undergone major surgery within the last 3 weeks before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that CAR T-cell therapy has been tested in various cancers, including prostate cancer. This treatment involves modifying a patient's T cells, a type of immune cell, to enhance their ability to fight cancer. In past studies, these modified T cells have shown promise, but ensuring safety remains a major focus.
For the treatment using L1CAM-specific CAR T cells, limited data exists due to the early stage of trials. These early trials primarily focus on safety, with researchers closely monitoring for side effects to ensure the treatment's safety.
Most CAR T-cell therapies in early studies have shown common side effects, such as flu-like symptoms, low blood cell counts, and fatigue. More serious side effects can occur, varying from person to person. The safety results from this trial will help determine the best dose and understand any risks.
While this treatment is not yet approved for prostate cancer, CAR T-cell therapies have received approval for other conditions, indicating some level of safety in similar treatments. However, each new therapy can have unique effects. Always consult a healthcare provider if there are concerns about joining a trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for prostate cancer, which often include surgery, radiation, and hormone therapy, this CAR T-cell therapy is unique because it uses genetically engineered T cells to specifically target L1CAM, a protein associated with cancer cells. Researchers are excited about this approach because CAR T-cell therapy has the potential to directly attack cancer cells while sparing healthy ones, offering a more precise treatment. Additionally, this therapy can adapt to the patient's immune system and potentially provide long-term protection against cancer recurrence.
What evidence suggests that this CAR T-cell therapy might be an effective treatment for prostate cancer?
Research has shown that CAR T-cell therapy could be a promising treatment for some cancers. This trial will study autologous T cells lentivirally transduced to express L1CAM-specific chimeric antigen receptors for small cell neuroendocrine prostate cancer (SCNPC). The goal is to modify T cells to target a protein called L1CAM on tumor cells. Early results suggest that these specially designed T cells can help the immune system effectively identify and destroy cancer cells. Patients with other types of cancer have responded well to similar CAR T-cell treatments, offering hope for this method in treating SCNPC.12346
Who Is on the Research Team?
Michael Schweizer
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for adults with small cell neuroendocrine prostate cancer that's advanced locally or spread elsewhere and can't be surgically removed. They must have had platinum-based chemo, no severe chronic respiratory illness, brain metastases, significant heart issues, uncontrolled infections or certain autoimmune diseases in the last 5 years. Participants need to agree to contraception use and have a life expectancy over 3 months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis and Bridging Therapy
Patients undergo leukapheresis to obtain PBMCs for T cell product manufacturing and may undergo bridging therapy
Lymphodepleting Chemotherapy and CAR T Cell Infusion
Patients undergo lymphodepleting chemotherapy followed by an autologous L1CAM-specific CAR+EGFRt+ T cell infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants may undergo long-term follow-up annually
What Are the Treatments Tested in This Trial?
Interventions
- Autologous T Cells Lentivirally Transduced to Express L1CAM-Specific Chimeric Antigen Receptors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Center
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania