The first patient has been dosed in a phase 2 clinical trial evaluating FK-PC101, a novel personalized cancer immunotherapy, for high-risk prostate cancer. The CELLVX-230 trial (NCT06636682) is a multicenter, adaptive, randomized, open-label study assessing the efficacy of FK-PC101 in men who have undergone radical prostatectomy. This immunotherapy aims to prevent recurrence in patients at high risk after surgical removal of the tumor, potentially delaying or preventing the need for salvage radiotherapy and androgen deprivation therapy (ADT).
FK-PC101 is an advanced autologous cellular vaccine created from a patient's own tumor cells, which are collected during surgery and modified in a specialized cGMP facility. The personalized vaccine presents 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.
CELLVX-230 Trial Design and Patient Eligibility
The CELLVX-230 trial is enrolling men with localized high-risk or very high-risk prostate cancer based on the National Comprehensive Cancer Network v4.2023 classification. Eligible patients must have at least 3 prostate biopsy cores with ≥50% tumor involvement, a prostate-specific antigen (PSA) level >4 ng/mL within 28 days before enrollment, and no evidence of distant metastases based on PSMA-PET/CT performed at least 28 days before enrollment. Enrolled patients must also have a life expectancy of greater than 5 years, be candidates 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 either the experimental arm or the active comparator arm. Patients in the experimental arm will receive up to 7 doses of FK-PC101 intradermally between day 1 and day 180. The immune adjuvant Bacillus Calmette-Guérin (BCG) will be administered concurrently with dose 1 (day 1) and dose 2 (day 8). The control group will receive standard of care.
All enrolled patients will undergo assessments at 60, 90, and 180 days, with follow-up visits continuing at months 10, 14, 18, and 22 post-randomization.
Endpoints and Anticipated Outcomes
The primary endpoint of the trial is disease-free survival. Secondary endpoints include time to next treatment, metastasis-free survival, immune response to FK-PC101, and safety and tolerability. An additional outcome measure is overall survival. All endpoints will be assessed for up to 22 months. Final completion of the CELLVX-230 trial is anticipated for May 2027.
According to Fernando Kreutz, CEO of CellVax, up to 30% of patients may still experience recurrent prostate cancer after prostatectomy, despite recent improvements in radiation, surgeries, and other therapies. The current standard of care after recurrence involves salvage radiotherapy and/or ADT, which can lead to poorer health-related quality of life. FK-PC101 aims to delay or prevent the necessity for such treatments.
