The phase 2 CELLVX-230 trial is assessing the potential of FK-PC101 to prevent prostate cancer recurrence and delay additional treatments post-surgery.
The first patient with prostate cancer has been dosed in a randomized, phase 2 clinical trial (NCT06636682) evaluating FK-PC101, a novel personalized cancer immunotherapy.1
FK-PC101 is an advanced autologous cellular vaccine designed to help prevent recurrence in patients with prostate cancer who are at high risk after surgical removal of the tumor.2 The personalized vaccine is made from the patient's own tumor cells collected during surgery, which are then modified in a specialized cGMP facility.
This personalized immunotherapy works by presenting unique tumor antigens to the immune system, activating both CD8-positive cytotoxic T cells and CD4-positive helper T cells. When administered, FK-PC101 introduces these cancer-specific neoantigens in the context of MHC I to activate CD8+ T cells, initiating a direct cytotoxic response. The agent also presents antigens to CD4-positive T cells through MHC II, creating a coordinated immune response, which primes the immune system for a targeted attack on cancer cells.2
“Despite recent improvements in radiation, surgeries, and other therapies, up to 30% of patients may still experience recurrent prostate cancer after prostatectomy," said Fernando Kreutz, chief executive officer of CellVax, in a press release.1 "Further, after such recurrence, the current standard of care is salvage radiotherapy and/or androgen deprivation therapy (ADT), both of which may lead to poorer health-related quality of life for patients. FK-PC101 could delay the necessity for such treatments, if not prevent them entirely.”
CELLVX-230 is a multicenter, adaptive, randomized, open-label, phase 2 trial examining FK-PC101 in men with high-risk prostate cancer following radical prostatectomy.3 Patients will undergo a 3-step screening and enrollment process.
Enrollment is open to patients with localized high-risk or very high-risk prostate cancer based on the National Comprehensive Cancer Network v4.2023 classification, those who have at least 3 prostate biopsy cores with ≥50% tumor involvement, prostate specific antigen >4 ng/mL 28 days or less before enrollment, and no evidence of distant metastases based on PSMA-PET/CT performed at least 28 days before enrollment. Those enrolled must also have a life expectancy of greater than 5 years, be a candidate for radical prostatectomy, have a scheduled radical prostatectomy 3 to 14 days after enrollment, and have never received neoadjuvant radiation therapy, ADT, or any other anticancer therapy.
After an initial safety run-in, patients will be randomized to the experimental arm or active comparator arm. In the first group, patients will be administered up to 7 doses of FK-PC101 intradermally between day 1 and day 180. The immune adjuvant Bacillus Calmette Guérin will be administered concurrently with dose 1 given on day 1 and dose 2 given on day 8. Subjects in the control group will receive standard of care.
Further, all patients enrolled will have assessments at 60 days, 90 days, and 180 days. Follow-up visits will continue at months 10, 14, 18, and 22 post-randomization.
Disease-free survival serves as the primary end point of the trial. Secondary end points include time to next treatment, metastasis-free survival, immune response to FK-PC101, and safety and tolerability.