CancerPhase 1/2CaReNCT06056791

Study of INKmune in Patients With mCRPC (CaRe Prostate)

A Phase 1/2 study testing INKmune in people with Cancer and Metastatic Castration-resistant Prostate Cancer, run by Inmune Bio, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Cancer, Metastatic Castration-resistant Prostate Cancer, mCRPC
What is being tested?: INKmune
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 8 sitesUnited States
Study dates: 30 Nov 2023to 10 Sep 2025
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.
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.
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.
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).
Subjects must be able to understand the potential risks and benefits of the study and be able to read and give written informed consent.

Who cannot join

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.

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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.
Expected survival of less than six months
At the time of consent, unable to comply with study procedures and assessments.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

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

Other trials in United States

About this study

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)

Read the 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.

Conditions: Cancer, Metastatic Castration-resistant Prostate Cancer, mCRPC
Being tested: INKmune
Keywords: mCRPC, NK Cell Based Therapy, Immune Mediated Therapy, Cell Therapy
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INKmuneBiological
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.

Study groups in NCT06056791
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Biological: INKmune

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 2-3 years
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
MTD identification, if available.
Measured: 2-3 years
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
Measurement of frequency and severity of adverse events (AEs).
Measured: 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).
Measured: 2-3 years

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202310 Sep 2025

First posted28 Sep 2023
Study start30 Nov 2023
Primary completion10 Sep 2025
Study completion10 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (58)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Dose escalation using mBOIN design
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06056791
Sponsor's protocol ID: INMB-INB16-003
Acronym: CaRe
Status last verified: Feb 2026
First submitted: 7 Aug 2023
Last updated: 27 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902
Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
PubMed 29313949
Center MM, Jemal A, Lortet-Tieulent J, Ward E, Ferlay J, Brawley O, Bray F. International variation in prostate cancer incidence and mortality rates. Eur Urol. 2012 Jun;61(6):1079-92. doi: 10.1016/j.eururo.2012.02.054. Epub 2012 Mar 8.
PubMed 22424666
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PubMed 25651787
Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Akinyemiju TF, Al Lami FH, Alam T, Alizadeh-Navaei R, Allen C, Alsharif U, Alvis-Guzman N, Amini E, Anderson BO, Aremu O, Artaman A, Asgedom SW, Assadi R, Atey TM, Avila-Burgos L, Awasthi A, Ba Saleem HO, Barac A, Bennett JR, Bensenor IM, Bhakta N, Brenner H, Cahuana-Hurtado L, Castaneda-Orjuela CA, Catala-Lopez F, Choi JJ, Christopher DJ, Chung SC, Curado MP, Dandona L, Dandona R, das Neves J, Dey S, Dharmaratne SD, Doku DT, Driscoll TR, Dubey M, Ebrahimi H, Edessa D, El-Khatib Z, Endries AY, Fischer F, Force LM, Foreman KJ, Gebrehiwot SW, Gopalani SV, Grosso G, Gupta R, Gyawali B, Hamadeh RR, Hamidi S, Harvey J, Hassen HY, Hay RJ, Hay SI, Heibati B, Hiluf MK, Horita N, Hosgood HD, Ilesanmi OS, Innos K, Islami F, Jakovljevic MB, Johnson SC, Jonas JB, Kasaeian A, Kassa TD, Khader YS, Khan EA, Khan G, Khang YH, Khosravi MH, Khubchandani J, Kopec JA, Kumar GA, Kutz M, Lad DP, Lafranconi A, Lan Q, Legesse Y, Leigh J, Linn S, Lunevicius R, Majeed A, Malekzadeh R, Malta DC, Mantovani LG, McMahon BJ, Meier T, Melaku YA, Melku M, Memiah P, Mendoza W, Meretoja TJ, Mezgebe HB, Miller TR, Mohammed S, Mokdad AH, Moosazadeh M, Moraga P, Mousavi SM, Nangia V, Nguyen CT, Nong VM, Ogbo FA, Olagunju AT, Pa M, Park EK, Patel T, Pereira DM, Pishgar F, Postma MJ, Pourmalek F, Qorbani M, Rafay A, Rawaf S, Rawaf DL, Roshandel G, Safiri S, Salimzadeh H, Sanabria JR, Santric Milicevic MM, Sartorius B, Satpathy M, Sepanlou SG, Shackelford KA, Shaikh MA, Sharif-Alhoseini M, She J, Shin MJ, Shiue I, Shrime MG, Sinke AH, Sisay M, Sligar A, Sufiyan MB, Sykes BL, Tabares-Seisdedos R, Tessema GA, Topor-Madry R, Tran TT, Tran BX, Ukwaja KN, Vlassov VV, Vollset SE, Weiderpass E, Williams HC, Yimer NB, Yonemoto N, Younis MZ, Murray CJL, Naghavi M. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2018 Nov 1;4(11):1553-1568. doi: 10.1001/jamaoncol.2018.2706.
PubMed 29860482
Negoita S, Feuer EJ, Mariotto A, Cronin KA, Petkov VI, Hussey SK, Benard V, Henley SJ, Anderson RN, Fedewa S, Sherman RL, Kohler BA, Dearmon BJ, Lake AJ, Ma J, Richardson LC, Jemal A, Penberthy L. Annual Report to the Nation on the Status of Cancer, part II: Recent changes in prostate cancer trends and disease characteristics. Cancer. 2018 Jul 1;124(13):2801-2814. doi: 10.1002/cncr.31549. Epub 2018 May 22.
PubMed 29786851
Flaig TW, Potluri RC, Ng Y, Todd MB, Mehra M. Treatment evolution for metastatic castration-resistant prostate cancer with recent introduction of novel agents: retrospective analysis of real-world data. Cancer Med. 2016 Feb;5(2):182-91. doi: 10.1002/cam4.576. Epub 2015 Dec 29.
PubMed 26710718
Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. doi: 10.1056/NEJMoa1405095. Epub 2014 Jun 1.
PubMed 24881730
Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10.
PubMed 23228172
Cheng HH, Gulati R, Azad A, Nadal R, Twardowski P, Vaishampayan UN, Agarwal N, Heath EI, Pal SK, Rehman HT, Leiter A, Batten JA, Montgomery RB, Galsky MD, Antonarakis ES, Chi KN, Yu EY. Activity of enzalutamide in men with metastatic castration-resistant prostate cancer is affected by prior treatment with abiraterone and/or docetaxel. Prostate Cancer Prostatic Dis. 2015 Jun;18(2):122-7. doi: 10.1038/pcan.2014.53. Epub 2015 Jan 20.
PubMed 25600186
Suzman DL, Luber B, Schweizer MT, Nadal R, Antonarakis ES. Clinical activity of enzalutamide versus docetaxel in men with castration-resistant prostate cancer progressing after abiraterone. Prostate. 2014 Sep;74(13):1278-85. doi: 10.1002/pros.22844. Epub 2014 Jul 22.
PubMed 25053178
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.
PubMed 15470213
de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.
PubMed 20888992
Crawford ED, Higano CS, Shore ND, Hussain M, Petrylak DP. Treating Patients with Metastatic Castration Resistant Prostate Cancer: A Comprehensive Review of Available Therapies. J Urol. 2015 Dec;194(6):1537-47. doi: 10.1016/j.juro.2015.06.106. Epub 2015 Jul 18.
PubMed 26196735

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT06056791
Acronym / sponsor ID: CaRe / INMB-INB16-003
Conditions: Cancer, Metastatic Castration-resistant Prostate Cancer, mCRPC
Keywords: mCRPC, NK Cell Based Therapy, Immune Mediated Therapy, Cell Therapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Inmune Bio, Inc.Industry (pharma, biotech, devices)
Study start: 30 Nov 2023 (actual)
Primary completion: 10 Sep 2025 (actual)
Study completion: 10 Sep 2025 (actual)
First posted: 28 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: Dose escalation using mBOIN design

Arm	Type	Receives
Cohort 1: 1 x 10^8 INKmune	Experimental	Biological: INKmuneIn 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.
Cohort 2: 3 x 10^8 INKmune	Experimental	Biological: INKmuneIn 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.
Cohort 3: 5 x 10^8 INKmune	Experimental	Biological: INKmuneIn 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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

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:

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INKmuneINKmune 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.	Biological	Cohort 1: 1 x 10^8 INKmune, Cohort 2: 3 x 10^8 INKmune, Cohort 3: 5 x 10^8 INKmune

Primary outcome

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.
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.
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.
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).
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).
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
Time frame: 2-3 years
MTD identification, if available.
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).
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).

9 secondary outcomes

Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing RECIST.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing disease response.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing disease response.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data.
Time frame: 2-3 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
Background: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
Background: PubMed 29313949Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
Background: PubMed 22424666Center MM, Jemal A, Lortet-Tieulent J, Ward E, Ferlay J, Brawley O, Bray F. International variation in prostate cancer incidence and mortality rates. Eur Urol. 2012 Jun;61(6):1079-92. doi: 10.1016/j.eururo.2012.02.054. Epub 2012 Mar 8.
Background: PubMed 25651787Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
Background: PubMed 29860482Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Akinyemiju TF, Al Lami FH, Alam T, Alizadeh-Navaei R, Allen C, Alsharif U, Alvis-Guzman N, Amini E, Anderson BO, Aremu O, Artaman A, Asgedom SW, Assadi R, Atey TM, Avila-Burgos L, Awasthi A, Ba Saleem HO, Barac A, Bennett JR, Bensenor IM, Bhakta N, Brenner H, Cahuana-Hurtado L, Castaneda-Orjuela CA, Catala-Lopez F, Choi JJ, Christopher DJ, Chung SC, Curado MP, Dandona L, Dandona R, das Neves J, Dey S, Dharmaratne SD, Doku DT, Driscoll TR, Dubey M, Ebrahimi H, Edessa D, El-Khatib Z, Endries AY, Fischer F, Force LM, Foreman KJ, Gebrehiwot SW, Gopalani SV, Grosso G, Gupta R, Gyawali B, Hamadeh RR, Hamidi S, Harvey J, Hassen HY, Hay RJ, Hay SI, Heibati B, Hiluf MK, Horita N, Hosgood HD, Ilesanmi OS, Innos K, Islami F, Jakovljevic MB, Johnson SC, Jonas JB, Kasaeian A, Kassa TD, Khader YS, Khan EA, Khan G, Khang YH, Khosravi MH, Khubchandani J, Kopec JA, Kumar GA, Kutz M, Lad DP, Lafranconi A, Lan Q, Legesse Y, Leigh J, Linn S, Lunevicius R, Majeed A, Malekzadeh R, Malta DC, Mantovani LG, McMahon BJ, Meier T, Melaku YA, Melku M, Memiah P, Mendoza W, Meretoja TJ, Mezgebe HB, Miller TR, Mohammed S, Mokdad AH, Moosazadeh M, Moraga P, Mousavi SM, Nangia V, Nguyen CT, Nong VM, Ogbo FA, Olagunju AT, Pa M, Park EK, Patel T, Pereira DM, Pishgar F, Postma MJ, Pourmalek F, Qorbani M, Rafay A, Rawaf S, Rawaf DL, Roshandel G, Safiri S, Salimzadeh H, Sanabria JR, Santric Milicevic MM, Sartorius B, Satpathy M, Sepanlou SG, Shackelford KA, Shaikh MA, Sharif-Alhoseini M, She J, Shin MJ, Shiue I, Shrime MG, Sinke AH, Sisay M, Sligar A, Sufiyan MB, Sykes BL, Tabares-Seisdedos R, Tessema GA, Topor-Madry R, Tran TT, Tran BX, Ukwaja KN, Vlassov VV, Vollset SE, Weiderpass E, Williams HC, Yimer NB, Yonemoto N, Younis MZ, Murray CJL, Naghavi M. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2018 Nov 1;4(11):1553-1568. doi: 10.1001/jamaoncol.2018.2706.
Background: PubMed 29786851Negoita S, Feuer EJ, Mariotto A, Cronin KA, Petkov VI, Hussey SK, Benard V, Henley SJ, Anderson RN, Fedewa S, Sherman RL, Kohler BA, Dearmon BJ, Lake AJ, Ma J, Richardson LC, Jemal A, Penberthy L. Annual Report to the Nation on the Status of Cancer, part II: Recent changes in prostate cancer trends and disease characteristics. Cancer. 2018 Jul 1;124(13):2801-2814. doi: 10.1002/cncr.31549. Epub 2018 May 22.
Background: PubMed 26710718Flaig TW, Potluri RC, Ng Y, Todd MB, Mehra M. Treatment evolution for metastatic castration-resistant prostate cancer with recent introduction of novel agents: retrospective analysis of real-world data. Cancer Med. 2016 Feb;5(2):182-91. doi: 10.1002/cam4.576. Epub 2015 Dec 29.
Background: PubMed 24881730Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. doi: 10.1056/NEJMoa1405095. Epub 2014 Jun 1.
Background: PubMed 23228172Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10.
Background: PubMed 25600186Cheng HH, Gulati R, Azad A, Nadal R, Twardowski P, Vaishampayan UN, Agarwal N, Heath EI, Pal SK, Rehman HT, Leiter A, Batten JA, Montgomery RB, Galsky MD, Antonarakis ES, Chi KN, Yu EY. Activity of enzalutamide in men with metastatic castration-resistant prostate cancer is affected by prior treatment with abiraterone and/or docetaxel. Prostate Cancer Prostatic Dis. 2015 Jun;18(2):122-7. doi: 10.1038/pcan.2014.53. Epub 2015 Jan 20.
Background: PubMed 25053178Suzman DL, Luber B, Schweizer MT, Nadal R, Antonarakis ES. Clinical activity of enzalutamide versus docetaxel in men with castration-resistant prostate cancer progressing after abiraterone. Prostate. 2014 Sep;74(13):1278-85. doi: 10.1002/pros.22844. Epub 2014 Jul 22.
Tracy, C. (2022). Prostate Cancer Treatment \& Management: Approach Considerations, Localized Prostate Cancer, Management of Advanced and Metastatic Disease.Link provided by the sponsor.
FDA (2021). Drug Development Tools: Fit-for-Purpose InitiativeLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tara Lehner study director

INmune Bio

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing INKmune in people with Cancer and Metastatic Castration-resistant Prostate Cancer, run by Inmune Bio, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC. (time frame: 2-3 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06056791, which also lists 58 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.