Study of INKmune in Patients With mCRPC (CaRe Prostate)

NCT06056791 | Completed Phase 1 FDA Drug

• 1 other identifier: INMB-INB16-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Cancer; mCRPC; Metastatic Castration-resistant Prostate Cancer

Keywords

mCRPC; NK Cell Based Therapy; Immune Mediated Therapy; Cell Therapy

Outcome Measures

Primary Outcomes (8)

• Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.

  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.

  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.

  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.

  Measurement of change in circulating tumor DNA (ctDNA).

  2-3 years

• Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.

  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.

  MTD identification, if available.

  2-3 years

• Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.

  Measurement of frequency and severity of adverse events (AEs).

  2-3 years

• Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.

  Measurement of frequency and severity of serious adverse events (SAEs).

  2-3 years

Secondary Outcomes (9)

• Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing RECIST.

  2-3 years

• Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.

  2-3 years

• Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.

  2-3 years

• Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.

  2-3 years

• Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data.

  2-3 years

Other Outcomes (9)

• Assess persistence of memory like Natural Killer (NK) cell number.

  2-3 years

• Explore the relationship between persistence of INKmune cells in patients treated with INKmune and disease response experienced through 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.

  1-169 Days

Study Arms (3)

Cohort 1: 1 x 10^8 INKmune

EXPERIMENTAL

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

Cohort 2: 3 x 10^8 INKmune

EXPERIMENTAL

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

Cohort 3: 5 x 10^8 INKmune

EXPERIMENTAL

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

Interventions

INKmune BIOLOGICAL

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.

Cohort 1: 1 x 10^8 INKmune; Cohort 2: 3 x 10^8 INKmune; Cohort 3: 5 x 10^8 INKmune

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects over 18 years of age at time of screening.
• Blood Prostate Specific Antigen (PSA) of \>1.0 ng/ml at time of screening.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at time of screening.
• Histologic confirmation of adenocarcinoma prostate cancer.
• 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.
• Castrate level of testosterone of \< 50 ng/dL.
• 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.

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• 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.
• 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.
• 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.
• 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.
• Clinically significant cardiac disease (New York Heart Association Class III/IV) or severe debilitating pulmonary disease.
• 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.
• Cytotoxic chemotherapy within three weeks prior to start of study treatment (Day 1).
• Radiation therapy within two weeks prior to start of study treatment (Day 1).
• Patients may not have received a previous NK based therapy.
• Evidence of central nervous system (CNS) metastatic disease at screening.
• Patients with an active infection requiring antibiotic treatment within seven days of starting study treatment (Day 1).
• Administration of live attenuated vaccines within eight weeks of start of study treatment (Day 1) and throughout the study.
• Any other medical condition that in the opinion of the Investigator may interfere with a subject's participation in, or compliance with, the study
• 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.

Sponsors & Collaborators

• Inmune Bio, Inc.: lead

Study Sites (8)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

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

Cincinnati, Ohio, 45219, United States

Location

Renovatio Clinical

El Paso, Texas, 79915, United States

Location

Renovatio Clinical

The Woodlands, Texas, 77380, United States

Location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

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Related Links

• Tracy, C. (2022). Prostate Cancer Treatment \& Management: Approach Considerations, Localized Prostate Cancer, Management of Advanced and Metastatic Disease.
• FDA (2021). Drug Development Tools: Fit-for-Purpose Initiative

MeSH Terms

Conditions

Neoplasms

Study Officials

• Tara Lehner

  INmune Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation using mBOIN design

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: September 28, 2023
• Study Start: November 30, 2023
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)