Study of INKmune in Patients With mCRPC (CaRe Prostate) (CaRe)

February 25, 2026 updated by: Inmune Bio, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Carl & Edyth Lindner Center for Research and Education at The Christ Hospital and The Christ Hospital Cancer Center
    • Texas
      • El Paso, Texas, United States, 79915
        • Renovatio Clinical
      • The Woodlands, Texas, United States, 77380
        • Renovatio Clinical
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • NEXT Virginia
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: 1 x 10^8 INKmune

In Dose Escalation: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 18 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below:

  • In Cohort 1, the initial planned dose is 1 x 10^8 INKmune;
  • In Cohort 2, the weekly dose will increase to 3 x 10^8 INKmune;
  • In Cohort 3, the weekly dose will increase to 5 x 10^8 INKmune.

In Dose Expansion: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 12 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below:

Following mBOIN termination and MTD identification, patients will be enrolled in up to two candidate optimal dose levels (no higher than the MTD) for final optimal dose determination.
Biological: INKmune
INKmune is a patented biologic delivery system and method for cancer treatment using in vivo priming and activation of natural killer (NK) cells in order to achieve tumor cell lysis. INKmune is a suspension of INB16 cells which have been rendered replication incompetent that does not require donor matching.
Experimental: Cohort 2: 3 x 10^8 INKmune

In Dose Escalation: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 18 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below:

  • In Cohort 1, the initial planned dose is 1 x 10^8 INKmune;
  • In Cohort 2, the weekly dose will increase to 3 x 10^8 INKmune;
  • In Cohort 3, the weekly dose will increase to 5 x 10^8 INKmune.

In Dose Expansion: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 12 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below:

Following mBOIN termination and MTD identification, patients will be enrolled in up to two candidate optimal dose levels (no higher than the MTD) for final optimal dose determination.
Biological: INKmune
INKmune is a patented biologic delivery system and method for cancer treatment using in vivo priming and activation of natural killer (NK) cells in order to achieve tumor cell lysis. INKmune is a suspension of INB16 cells which have been rendered replication incompetent that does not require donor matching.
Experimental: Cohort 3: 5 x 10^8 INKmune

In Dose Escalation: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 18 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below:

  • In Cohort 1, the initial planned dose is 1 x 10^8 INKmune;
  • In Cohort 2, the weekly dose will increase to 3 x 10^8 INKmune;
  • In Cohort 3, the weekly dose will increase to 5 x 10^8 INKmune.

In Dose Expansion: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 12 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below:

Following mBOIN termination and MTD identification, patients will be enrolled in up to two candidate optimal dose levels (no higher than the MTD) for final optimal dose determination.
Biological: INKmune
INKmune is a patented biologic delivery system and method for cancer treatment using in vivo priming and activation of natural killer (NK) cells in order to achieve tumor cell lysis. INKmune is a suspension of INB16 cells which have been rendered replication incompetent that does not require donor matching.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Time Frame: 2-3 years
Measurement of peripheral blood activated NK cell (memory like NK cell phenotype) percentage by flow cytometry to >2 times pre-treatment percentage.
2-3 years
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Time Frame: 2-3 years
Measurement of Prostate Specific Antigen (PSA) to determine the percent of patients that decrease PSA by ≥30% during treatment.
2-3 years
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Time Frame: 2-3 years
Measurement of disease burden as determined by prostate-specific membrane antigen (PMSA) positron emission tomography (PET) scan.
2-3 years
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Time Frame: 2-3 years
Measurement of change in circulating tumor DNA (ctDNA).
2-3 years
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
Time Frame: 2-3 years
Measurement of frequency and severity of Dose-Limiting Toxicities (DLT).
2-3 years
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
Time Frame: 2-3 years
MTD identification, if available.
2-3 years
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
Time Frame: 2-3 years
Measurement of frequency and severity of adverse events (AEs).
2-3 years
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
Time Frame: 2-3 years
Measurement of frequency and severity of serious adverse events (SAEs).
2-3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing RECIST.
Time Frame: 2-3 years
Assessment based on current Prostate Cancer Working Group 3 (PCWG3) modified Response Evaluation Criteria (RECIST) Version 1.1, where applicable.
2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.
Time Frame: 2-3 years
Measurement of PSA response using PSA50 response rate.
2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.
Time Frame: 2-3 years
Measurement of the period of time PSA decrease by ≥30%.
2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.
Time Frame: 2-3 years
Measurement of the period of time PSA is below baseline.
2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data.
Time Frame: 2-3 years
Measurement of Progression Free Survival (PFS).
2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data.
Time Frame: 2-3 years
Measurement of Radiological Progression Free Survival (rPFS).
2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing disease response.
Time Frame: 2-3 years
Measurement of Objective response rate (ORR)
2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing disease response.
Time Frame: 2-3 years
Measurement of the Disease control rate.
2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data.
Time Frame: 2-3 years
Measurement of Overall survival (OS).
2-3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess persistence of memory like Natural Killer (NK) cell number.
Time Frame: 2-3 years
Assess persistence of memory like Natural Killer (NK) cell number.
2-3 years
Determine endogenous NK cell infiltration from optional biopsy tissue and previously resected tissue (if available).
Time Frame: 2-3 years
Optional biopsy tissue and previously resected tissue will be analyzed with Immunohistochemistry (IHC) and RNA sequencing of patient pathological specimens.
2-3 years
Determine stromal expression of inhibitory ligands from optional biopsy tissue and previously resected tissue (if available).
Time Frame: 2-3 years
Optional biopsy tissue and previously resected tissue will be analyzed with Immunohistochemistry (IHC) and RNA sequencing of patient pathological specimens.
2-3 years
Complete transcriptomic analyses from optional biopsy tissue and previously resected tissue (if available).
Time Frame: 2-3 years
Optional biopsy tissue and previously resected tissue will be analyzed with Immunohistochemistry (IHC) and RNA sequencing of patient pathological specimens.
2-3 years
Evaluate activity of INKmune therapy in relation to the sequence of mCRPC treatment received by patients.
Time Frame: 2-3 years
Outcome will be evaluated by review of medical history and collection of safety follow-up visits to record mCRPC treatments after completion of clinical trial in comparison to peripheral blood activated NK cell (memory like NK cell phenotype) percentage by flow cytometry.
2-3 years
Assess the experience of clinical trial participation by patients through a comprehensive patient survey provided post visit at 3 timepoints during the trial.
Time Frame: 1-2 years

Quality Improvement: Assess the experience of clinical trial participation by patients through patient questionnaires collected throughout the clinical trial. Questionnaires will be provided at 3 time points during study participation following study visits.

Understand the patient experiences across participation in the clinical trial, through patient questionnaires (answers to be selected on a scale from '1 to 5', with '1' being very poor and '5' being very good), to assess patient perceptions in the following areas:

  • Access,
  • Communication,
  • Information & materials,
  • Patient burden,
  • Patient centeredness,
  • Privacy,
  • Quality of care,
  • Trust,
  • Safety.
1-2 years
Explore the relationship between persistence of INKmune cells in patients treated with INKmune and disease response experienced through Day 169.
Time Frame: 1-169 Days
Relationship will be explored through multi-parameter flow cytometry and tumor killing of NK resistant tumor targets (RAJI cells) in blood of patients after treatment with INKmune. Disease response will be assessed from RECIST, PSMA, PSA data.
1-169 Days
Determine the concentration of circulating tumor DNA (ctDNA) levels and treatment response in patients with ctDNA data.
Time Frame: 1-169 Days
Relationship between ctDNA levels and treatment response will be assessed by collection of serial ctDNA assays in patients with available pre-treatment tumor DNA. ctDNA collections will occur at Day 1, Day 57 and Day 169.
1-169 Days
Determine change in blood PSA levels compared to change in tumor burden, as assessed by RECIST v1.1, and Pylarify PSMA PET scan (piflufolastat F 18) for each patient treated with INKmune.
Time Frame: 1-169 Days
Relationship between blood PSA levels and change in tumor burden will be assessed through collection of serum PSA level and measurable disease burden assessed by RECIST v1.1, PCWG3 criteria, and Pylarify PSMA PET scan (piflufolastat F 18). PSA will be collected at Screening and at each visit following the 3 doses of INKmune. PSMA PET scans will be completed at Day 1, Day 57 and Day 169.
1-169 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inmune Bio, Inc.

Investigators

  • Study Director: Tara Lehner, INmune Bio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2023

Primary Completion (Actual)

September 10, 2025

Study Completion (Actual)

September 10, 2025

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INMB-INB16-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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