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Study of INKmune in Patients With mCRPC (CaRe Prostate) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study of INKmune in Patients With mCRPC (CaRe Prostate)

An Open-label, Phase I/IIa Dose Escalation and Expansion Study to Determine the Safety and Clinical Activity of an Immune Priming Cell Therapy (INKmune) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

NCT06056791•Inmune Bio, Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, phase I/IIa dose escalation and expansion study of INKmune in men with mCRPC. INKmune is administered to patients intravenously over three doses, at least one-week apart. The study will consist of two stages.

Detailed Description

This is an open-label, phase I/IIa dose escalation and expansion study of INKmune in men with mCRPC. INKmune is administered to patients intravenously over 3 doses. The 3 infusions will occur over a minimum of a 2-week period, with each infusion at least 1 week apart. The study will consist of 2 stages: * Dose escalation: exploring dose levels of 1x10\^8, 3x10\^8, and 5x10\^8 cells per infusion. * Dose expansion: following mBOIN termination and maximum tolerated dose (MTD) identification, patients will be enrolled in up to 2 candidate optimal dose levels for final optimal dose determination. Eligible patients will sign informed consent prior to any study assessments being performed. Patients have up to 30 days in which to have all screening procedures and eligibility assessed. Patients will be infused with INKmune on Days 1, 8, and 15. Patients will also present to site on days 29, 57, 85, 113, and 141 to complete study assessments. Day 169 is the last study visit and patient will have completed trial after this visit has been completed. Option to enroll in the INKmune Long term Follow-up Registry will be presented at Day 169 visit.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Male subjects over 18 years of age at time of screening.
•2. Blood Prostate Specific Antigen (PSA) of \>1.0 ng/ml at time of screening.
•3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at time of screening.
•4. Histologic confirmation of adenocarcinoma prostate cancer.
•5. A diagnosis of progressive metastatic castrate resistant prostate cancer (mCRPC), as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3), following androgen deprivation therapy (ADT) and at least one androgen receptor signaling inhibitor, but not more than 3 therapies in addition to ADT. Progressive disease at the time of study entry as indicated by at least one of the following:
•* i. At least two rising PSA values at a minimum of a one-week interval. If PSA is the only measure of progression, then the minimum PSA value at the start of treatment must be ≥ 1 ng/mL.
•* ii. Radiographic progression per RECIST1.1 for soft tissue (at least 1 measurable lesion per RECIST 1.1), and/or
•* iii. Progression of bone metastases.
•6. Castrate level of testosterone of \< 50 ng/dL.
•7. Adequate organ function indicated by the following laboratory parameters:
+13 more criteria

Exclusion Criteria

•The participant may not enter the study if ANY of the following apply:
•1. Diagnosis of small cell/neuroendocrine prostate cancer. Immunohistochemical staining for neuroendocrine markers (e.g., chromogranin A, neuron-specific enolase, and synaptophysin) is not sufficient to establish a small cell/neuroendocrine histology; morphologic features that are characteristic of small cell/neuroendocrine prostate cancer are required to confirm the presence of small cell/neuroendocrine prostate cancer.
•2. History of concurrent malignant cancer within previous 3 years, with the exception of in situ carcinomas and non-melanoma skin cancer. If diagnosis or treatment for other cancers have occurred in the last 3 years, further discussion needed.
•3. Uncontrolled autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, temporal arteritis, and thyroiditis. Autoimmune conditions that are well-controlled in the opinion of the investigator must first be discussed with the Sponsor prior to enrollment.
•4. A requirement for daily systemic corticosteroids for any reason; or other immunosuppressive or immunomodulatory agents. Topical, nasal, modified-release oral, and/or physiologic corticosteroids may be permitted following discussion with the Sponsor.
•5. Clinically significant cardiac disease (New York Heart Association Class III/IV) or severe debilitating pulmonary disease.
•6. Patients with a current or recent history, as determined by the Investigator, of clinically significant, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastroenterological, or neurological disease.
•7. Cytotoxic chemotherapy within three weeks prior to start of study treatment (Day 1).
•8. Radiation therapy within two weeks prior to start of study treatment (Day 1).
•9. Patients may not have received a previous NK based therapy.
+7 more criteria

Locations (8)

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Carl & Edyth Lindner Center for Research and Education at The Christ Hospital and The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

Renovatio Clinical

El Paso, Texas, United States

Renovatio Clinical

The Woodlands, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

VA Puget Sound Health Care System

Seattle, Washington, United States

Key Dates

Start Date

November 30, 2023

Primary Completion Date

September 10, 2025

Completion Date

September 10, 2025

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

CancerMetastatic Castration-resistant Prostate CancermCRPC

Interventions

INKmune

BIOLOGICAL

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RECRUITINGPHASE2

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of INKmune in Patients With mCRPC (CaRe Prostate)

Inclusion Criteria

Exclusion Criteria

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers

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