INmune Bio Inc. has announced the expansion of its Phase 2 CaRe PC trial (NCT06056791) to the West Los Angeles VA Medical Center, marking the enrollment of the first veteran with metastatic castration-resistant prostate cancer (mCRPC). This open-label Phase 1/2 study is evaluating the safety and anti-tumor activity of INKmune, a natural killer (NK) cell-targeted therapy, across three dose levels.
The trial's expansion to the Veterans Health Administration aims to leverage its large integrated healthcare system to provide access to a diverse patient population. According to INmune Bio CEO, RJ Tesi, MD, the VA is an ideal place to perform clinical trials.
Trial Design and Endpoints
The CaRe PC trial is designed to assess the safety and efficacy of INKmune in mCRPC patients. Participants receive up to three doses of INKmune on days 1, 8, and 15, at low (1 x 108 INKmune), medium (3 x 108 INKmune), or high (5 x 108 INKmune) dose levels. The Phase 1 portion employed a 3x3 dose escalation design, while Phase 2 will evaluate safe dose levels simultaneously, with up to 10 patients per cohort.
Patients are followed for six months post-treatment to evaluate immunologic and anti-cancer responses. Immune responses are measured by assessing the number of tumor-killing memory-like NK cells and their duration in circulation. Anti-tumor responses are monitored via prostatic-specific antigen (PSA) levels, AI-quantified metastatic lesions on prostate-specific membrane antigen imaging with piflufolastat F 18 (Pylarify), and circulating tumor DNA levels.
The primary goals are to determine INKmune's safety in mCRPC patients and to identify a recommended dose for a future randomized registration trial.
Initial Phase 1 Data
Initial data from the Phase 1 portion, presented in September 2024, included three patients at the lowest dose level. All patients exhibited changes in NK cell phenotype and function, sustained for over 40 days post-INKmune infusion. Two patients showed increased circulating activated NK cells, and one experienced a transient 21% decrease in PSA associated with increased NK cell activity.
At the time of the data release, the second cohort had completed dosing, with the third cohort planned to commence dosing shortly thereafter. The study is expected to be completed in November 2025.
Expert Commentary
Matthew Rettig, MD, Chief of Hematology-Oncology at the VA Greater Los Angeles Healthcare System and principal investigator, highlighted the novel approach of the INmune Bio study. "The INmune Bio study represents a new immune therapy approach to treating advanced prostate cancer... Unlike most immunotherapies, this study involves treatment that is given as an outpatient and appears to have minimal side effects, which helps the management of prostate cancer among Veterans and the US population at large."
