Trial of immune therapy in mCRPC expands enrollment to VA medical center

The phase 2 portion of the CaRe PC trial (NCT06056791)—evaluating the natural killer (NK) cell targeted therapy INKmune in patients with metastatic castration-resistant prostate cancer (mCRPC)—has been initiated with the dosing of the first patient from the West Los Angeles VA Medical Center, INmune Bio announced in a news release.¹

The study's primary goals are to assess the safety of INKmune and to determine a recommended dose level.

This dosing also marks the official expansion of the trial to veterans with mCRPC.

“The Veterans Health Administration is an ideal place to perform clinical trials,” said RJ Tesi, MD, CEO of INmune Bio, in the news release.¹ “It is a large integrated health care system that provides high-quality medical care to a diverse population of patients.”

The first patient received the “medium” dose level of INKmune in the trial.

Overall, the open-label phase 1/2 study is assessing the safety and anti-tumor activity of INKmune across 3 dose levels. Patients may receive up to 3 doses of INKmune (given on days 1, 8, and 15) at a dose level of either low (1 x 108 INKmune), medium (3 x 108 INKmune), or high (5 x 108 INKmune).

In phase 1, the doses were evaluated in a 3x3 dose escalation design. In the phase 2 portion of the study, the dose levels determined to be safe will be evaluated simultaneously, with each dose cohort including up to 10 patients.

Those enrolled in the study will be followed for 6 months after treatment to assess their immunologic and anti-cancer responses to therapy. Immune responses will be measured by the number of tumor killing memory-like NK cells in the patient’s blood and how long those specialized NK cells remain in circulation. The investigators will measure anti-tumor responses by monitoring the level of prostatic-specific antigen (PSA) in the blood, using artificial intelligence to quantify the number and size of metastatic lesions on prostate-specific membrane antigen imaging with piflufolastat F 18 (Pylarify), and by measuring circulating tumor DNA in the blood.

The primary goals of the study are to assess the safety of INKmune in patients with mCRPC and to determine a recommended dose level to be used in a blinded, randomized registration trial.

“The INmune Bio study represents a new immune therapy approach to treating advanced prostate cancer. The study involves the use of cellular therapy treatment that activates NK cells, which are immune cells known to target tumor cells and are in relative abundance in prostate cancer,” said principal investigator Matthew Rettig, MD, Chief of Hematology-Oncology at the VA Greater Los Angeles Healthcare System, in the news release.¹ “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.”

Data from CaRe PC

Initial data from phase 1 portion of the trial were shared in September 2024.² The findings spanned the 3 patients enrolled in the lowest dose level in the study.

All 3 patients showed changes in the phenotype and function of their NK cells, and all 3 patients’ increase in NK cell function was sustained for more than 40 days following the final infusion of INKmune. Two patients showed an increase in their circulating activated NK cells, and 1 patient “showed a transient 21% decrease in [prostate-specific antigen] associated with the increase in NK cell activity and function,” the company reported.

At the time of data report, the investigators had completed dosing of patients in the second cohort, with plans to begin dosing the third cohort in the 30 days following.

Final study completion, encompassing both phase 1 and phase 2, is expected in November 2025.³

References

1. INmune Bio Inc. expands INKmune trial in prostate cancer to veterans. News release. INmune Bio, Inc. Published online and accessed January 28, 2025. https://www.inmunebio.com/index.php/newsroom/2025-news/muneioncxpandsmunerialinrostateancerto20250128050502

2. INKmune demonstrates excellent safety and increased NK-cell activity in first dosing cohort. News release. September 26, 2024. Accessed January 28, 2025. https://www.inmunebio.com/index.php/newsroom/2024-news/muneemonstratesxcellentafetyandncreasede20240926050502

3. Study of INKmune in patients with mCRPC (CaRe Prostate) (CaRe). ClinicalTrials.gov. Last updated November 7, 2024. Accessed January 28, 2025. https://clinicaltrials.gov/study/NCT06056791