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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06056791
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : March 26, 2024
Sponsor:
Information provided by (Responsible Party):
Inmune Bio, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Metastatic Castration-resistant Prostate Cancer mCRPC Biological: INKmune Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation using mBOIN design
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 30, 2023
Estimated Primary Completion Date : May 30, 2025
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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).

  5. 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).

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

  7. 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).

  8. 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).


Secondary Outcome Measures :
  1. 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. 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.

  3. 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%.

  4. 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.

  5. Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data. [ Time Frame: 2-3 years ]
    Measurement of Progression Free Survival (PFS).

  6. 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).

  7. Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing disease response. [ Time Frame: 2-3 years ]
    Measurement of Objective response rate (ORR)

  8. Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing disease response. [ Time Frame: 2-3 years ]
    Measurement of the Disease control rate.

  9. Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data. [ Time Frame: 2-3 years ]
    Measurement of Overall survival (OS).


Other Outcome Measures:
  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06056791


Contacts
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Contact: Nicole Kay-Mindick 386 852 2361 nmindick@inmunebio.com

Locations
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United States, California
VA Greater Los Angeles Healthcare System Not yet recruiting
Los Angeles, California, United States, 90073
Principal Investigator: Matthew Rettig, MD         
University of California, Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Matthew Rettig, MD         
United States, Nevada
Comprehensive Cancer Centers of Nevada Not yet recruiting
Las Vegas, Nevada, United States, 89169
Principal Investigator: Kyaw Thein, MD         
United States, Ohio
Carl & Edyth Lindner Center for Research and Education at The Christ Hospital and The Christ Hospital Cancer Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Abby Reed    513-585-1140    abby.reed@thechristhospital.com   
Principal Investigator: Alexander Starodub, MD         
United States, Texas
Renovatio Clinical Recruiting
El Paso, Texas, United States, 79915
Contact: Maya Fleyhan    713-703-2398    maya.fleyhan@renovatioclinical.com   
Principal Investigator: Haroutioun Shahinian, MD         
Renovatio Clinical Recruiting
The Woodlands, Texas, United States, 77380
Contact: Pablo Villarreal    713-703-2398    pablo.villarreal@renovatioclinical.com   
Principal Investigator: Jonathan Lu, MD         
United States, Virginia
NEXT Virginia Recruiting
Fairfax, Virginia, United States, 22031
Contact: Blake Patterson    703-783-4505    bpatterson@nextoncology.com   
Principal Investigator: M. Adham Salkeni, MD         
United States, Washington
VA Puget Sound Health Care System Not yet recruiting
Seattle, Washington, United States, 98108
Principal Investigator: Robert (Bruce) Montgomery, MD         
Sponsors and Collaborators
Inmune Bio, Inc.
Investigators
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Study Director: Tara Lehner INmune Bio
More Information
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Additional Information:

Publications:
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.
James ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Spears MR, Ritchie AW, Parker CC, Russell JM, Attard G, de Bono J, Cross W, Jones RJ, Thalmann G, Amos C, Matheson D, Millman R, Alzouebi M, Beesley S, Birtle AJ, Brock S, Cathomas R, Chakraborti P, Chowdhury S, Cook A, Elliott T, Gale J, Gibbs S, Graham JD, Hetherington J, Hughes R, Laing R, McKinna F, McLaren DB, O'Sullivan JM, Parikh O, Peedell C, Protheroe A, Robinson AJ, Srihari N, Srinivasan R, Staffurth J, Sundar S, Tolan S, Tsang D, Wagstaff J, Parmar MK; STAMPEDE investigators. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016 Mar 19;387(10024):1163-77. doi: 10.1016/S0140-6736(15)01037-5. Epub 2015 Dec 21.

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Responsible Party: Inmune Bio, Inc.
ClinicalTrials.gov Identifier: NCT06056791    
Other Study ID Numbers: INMB-INB16-003
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: March 26, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inmune Bio, Inc.:
mCRPC
NK Cell Based Therapy
Immune Mediated Therapy
Cell Therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases