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Experimental cell therapy aims to boost immune system against Hard-to-Treat prostate cancer

NCT ID NCT06056791

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested an experimental cell therapy called INKmune in 12 men with advanced prostate cancer that no longer responds to hormone therapy. The goal was to find the safest and most effective dose by measuring immune cell activity, PSA levels, and tumor changes. The treatment is given as three intravenous doses, and the study focused on safety and signs of disease control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

12 people

The number who actually took part.

Started

Nov 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * i. Hemoglobin ≥ 8.0 g/dL. * ii. White Blood Cell Count (WBC) ≥ 3.0 x 10⁹/L. * iii. Lymphocytes ≥ 80% LLN * iv. Absolute Neutrophil Count (ANC) ≥ 1.5 x 10⁹/L. * v. Platelets ≥ 100 x 10⁹/L. * vi. PT and APTT \< 1.5x ULN (unless receiving therapeutic anticoagulation). * vii. AST or ALT ≤ 2.5x ULN. AST or ALT ≤ 5x ULN for patients with liver metastases. * viii. Bilirubin \< 1.5x ULN (\< 3x ULN in Gilbert's Syndrome). * ix. Creatinine clearance/estimated GFR ≥ 30 mL/min (MDRD or Cockcroft-Gault). * x. Resting room air PaO2 saturation of \>95% as measured by pulse oximetry. 8. Negative screen for Human Immunodeficiency virus (HIV), Hepatitis B virus (HBV) antigen, and Hepatitis C virus (HCV). If testing was done within the past three months, there is no need to repeat testing if documentation of results is provided to the study site. 9. Subjects and their partners of reproductive potential must agree to use an effective form of contraception during the period of drug administration and for three months following the completion of the last administration of the study drug. An effective form of contraception is defined as oral contraceptives plus one form of barrier method or double barrier methods (condom with spermicide or condom with diaphragm). 10. Subjects must be able to understand the potential risks and benefits of the study and be able to read and give written informed consent. 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. 10. Evidence of central nervous system (CNS) metastatic disease at screening. 11. Patients with an active infection requiring antibiotic treatment within seven days of starting study treatment (Day 1). 12. Administration of live attenuated vaccines within eight weeks of start of study treatment (Day 1) and throughout the study. 13. Any other medical condition that in the opinion of the Investigator may interfere with a subject's participation in, or compliance with, the study 14. Participation in a therapeutic research study or receipt of an investigational drug within 4 weeks of start of treatment (Day 1) or 5 half-lives, whichever occurs first. 15. Expected survival of less than six months 16. At the time of consent, unable to comply with study procedures and assessments.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Cincinnati, Ohio, 45219, United States

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • NEXT Virginia

    Fairfax, Virginia, 22031, United States

  • Renovatio Clinical

    El Paso, Texas, 79915, United States

  • Renovatio Clinical

    The Woodlands, Texas, 77380, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073, United States

  • VA Puget Sound Health Care System

    Seattle, Washington, 98108, United States

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