ACTIVE_NOT_RECRUITING

Study of INKmune in Patients With mCRPC (CaRe Prostate)

Conditions

Cancer Metastatic Castration-resistant Prostate Cancer mCRPC NK Cell Based Therapy Immune Mediated Therapy Cell Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 three doses, at least one-week apart. The study will consist of two stages.

Official Title

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)

Quick Facts

Study Start:2023-11-30

Study Completion:2025-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06056791

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Tara Lehner

STUDY_DIRECTOR

INmune Bio

Study Locations (Sites)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073

United States

University of California, Los Angeles

Los Angeles, California, 90095

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169

United States

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

Cincinnati, Ohio, 45219

United States

Renovatio Clinical

El Paso, Texas, 79915

United States

Renovatio Clinical

The Woodlands, Texas, 77380

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

VA Puget Sound Health Care System

Seattle, Washington, 98108

United States

Collaborators and Investigators

Sponsor: Inmune Bio, Inc.

Tara Lehner, STUDY_DIRECTOR, INmune Bio

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 Registration Dates

Study Start Date2023-11-30

Study Completion Date2025-11-30

Study Record Updates

Study Start Date2023-11-30

Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

mCRPC
NK Cell Based Therapy
Immune Mediated Therapy
Cell Therapy

Additional Relevant MeSH Terms

Cancer
Metastatic Castration-resistant Prostate Cancer
mCRPC