INKmune for Prostate Cancer

(CaRe Trial)

Not currently recruiting at 7 trial locations

Overseen By Nicole Kay-Mindick

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Inmune Bio, Inc.

Must be taking: Androgen deprivation

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Small cell cancer, Autoimmune, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called INKmune for men with advanced prostate cancer that no longer responds to traditional hormone therapy. The study aims to find the best dose of INKmune by gradually increasing the amount given to participants. The treatment is administered through a slow intravenous injection over three weeks. Men with progressive metastatic castrate-resistant prostate cancer (mCRPC) who have experienced rising PSA levels (a protein made by prostate cells) despite previous treatments might be a good fit for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you require daily systemic corticosteroids or other immunosuppressive agents. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that INKmune is likely to be safe for humans?

Research has shown that INKmune is well-tolerated and safe for patients with advanced prostate cancer that no longer responds to hormone therapy. In previous studies, researchers tested INKmune at three different doses. They found it safe and effective in activating natural killer (NK) cells in more than half of the patients. Importantly, no serious side effects were reported, and the treatment was well-tolerated at all doses. This suggests that INKmune could be a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

INKmune is unique because it offers a novel approach to treating prostate cancer by harnessing the power of natural killer (NK) cells. Unlike traditional treatments like hormone therapy or chemotherapy, which target cancer cells directly, INKmune activates and enhances the body's own immune system, specifically the NK cells, to fight against cancer cells. Researchers are excited about this treatment because it represents a shift from directly targeting cancer cells to empowering the immune system to do the job, potentially leading to fewer side effects and more targeted action against cancerous cells.

What evidence suggests that INKmune might be an effective treatment for prostate cancer?

Research shows that INKmune may help treat advanced prostate cancer unresponsive to standard hormone therapy. In this trial, participants will receive different doses of INKmune across separate treatment arms. Studies have found that INKmune activates special white blood cells called natural killer (NK) cells in more than half of the patients with this type of cancer. These NK cells are important because they help fight cancer cells. The treatment has also proven safe for patients, which is a significant advantage. Overall, early results suggest that INKmune might help slow the progression of this difficult-to-treat cancer. ^{2 3 4 5 6}

Who Is on the Research Team?

Tara Lehner

Principal Investigator

INmune Bio

Are You a Good Fit for This Trial?

Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has progressed after treatment. They must have a PSA level >1.0 ng/ml, be in good physical condition (ECOG 0-1), and agree to use effective contraception during the study and for three months after.

Inclusion Criteria

Your hemoglobin must be at least 8.0 g/dL, your white blood cell count (WBC) 3.0 x 10⁹/L or higher, lymphocytes 80% LLN or more, absolute neutrophil count (ANC) 1.5 x 10⁹/L and up, platelets 100 x 101²/L minimum; prothrombin time (PT) and activated partial thromboplastin time (APTT) less than 1.5x upper limit of normal unless receiving therapeutic anticoagulation; aspartate aminotransferase (AST)/alanine

Your bilirubin level is below 1.5x the upper limit of normal (< 3x ULN in Gilbert's Syndrome), your creatinine clearance/estimated GFR must be at least 50 mL/min (MDRD or Cockcroft-Gault) and your resting room air PaO2 saturation needs to measure above 95% as measured by pulse oximetry.

Subjects and their partners of reproductive potential must agree to use a combination of oral contraceptives with at least one form of barrier method or double-barrier methods (condom with spermicide or condom with diaphragm) as an effective form of contraception during the period in which the study drug is administered, and for three months following.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Dose Escalation

INKmune therapy is administered by slow intravenous injection at escalating doses to determine the maximum tolerated dose

3 weeks

3 visits (in-person) on Days 1, 8, and 15

Dose Expansion

Patients receive INKmune therapy at optimal dose levels determined from the dose escalation phase

3 weeks

3 visits (in-person) on Days 1, 8, and 15

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

5 visits (in-person) on Days 29, 57, 85, 113, and 141

Long-term Follow-up Registry (optional)

Participants may opt into a registry for long-term follow-up to assess the persistence of treatment effects

What Are the Treatments Tested in This Trial?

Interventions

• INKmune

Trial Overview The trial is testing INKmune, given intravenously in three doses at least one week apart. It's an open-label phase I/IIa study which means everyone gets the drug, and it includes dose escalation to find the right amount followed by expansion to see how well it works.

How Is the Trial Designed?

Group I: Cohort 3: 5 x 10^8 INKmune Experimental Treatment 1 Intervention

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.

Group II: Cohort 2: 3 x 10^8 INKmune Experimental Treatment 1 Intervention

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.

Group III: Cohort 1: 1 x 10^8 INKmune Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Inmune Bio, Inc.

Lead Sponsor

Trials

7

Recruited

340+

Published Research Related to This Trial

Sipuleucel-T is an autologous cellular immunotherapy that effectively stimulates the immune system to target prostate cancer, leading to prolonged overall survival in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (CRPC).

The findings from phase III studies highlight the efficacy and safety of sipuleucel-T, suggesting its important role in the treatment of advanced prostate cancer and indicating potential directions for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T for the treatment of advanced prostate cancer. Frohlich, MW.[2016]

Sipuleucel-T is the first cell-based immune therapy approved for prostate cancer, indicating that the immune system can potentially influence this type of solid tumor.

Current immunological treatments, including various vaccines and checkpoint inhibitors, have not shown significant antitumor effects on their own, suggesting that combining these therapies with other treatments like chemotherapy or radiation may improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy in metastatic prostate cancer. Slovin, SF.[2020]

Sipuleucel-T is currently the only approved immunotherapy for prostate cancer, but new agents like personalized peptide vaccines show promise in improving overall survival in early clinical trials.

While some monoclonal antibody therapies have not shown significant survival benefits alone, combining them with other treatments has yielded encouraging results, suggesting that a tailored approach to immunotherapy could enhance efficacy in prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising immunotherapy for prostate cancer. Henegan, JC., Sonpavde, G.[2019]

Sipuleucel-T has been shown to improve overall survival in patients with advanced castration-resistant prostate cancer, highlighting the potential of immunotherapy to harness the immune system for long-term cancer treatment.

Prostate tumors can evade immune detection, suggesting the need for multiple therapeutic strategies, including vaccines and T-cell modulation, to enhance the effectiveness of immunotherapy in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy for castration-resistant prostate cancer: Progress and new paradigms. Quinn, DI., Shore, ND., Egawa, S., et al.[2022]

Sipuleucel-T is the first approved cancer vaccine that enhances T-cell immunity specifically against metastatic castration-resistant prostate cancer, marking a significant advancement in cancer treatment.

Ongoing research includes other prostate cancer vaccines like PROSTVAC-VF and GVAX, as well as clinical trials exploring immune checkpoint inhibitors like ipilimumab and nivolumab, which help reactivate T cells to fight cancer more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular insights into the development of T cell-based immunotherapy for prostate cancer. Dong, B., Minze, LJ., Xue, W., et al.[2018]

Cytokine-based therapies, such as those targeting IL-2, IL-15, and IL-12, offer a promising alternative to traditional T-cell focused immunotherapies for prostate cancer, as they can engage a broader range of immune cells in the tumor microenvironment.

Current strategies using immune checkpoint inhibitors have not improved outcomes in unselected prostate cancer patients, highlighting the need for new approaches that consider the complex interactions of various immune cell types, including natural killer cells and macrophages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Signaling new therapeutic opportunities: cytokines in prostate cancer. Chandran, E., Meininger, L., Karzai, F., et al.[2022]

Prostate cancer has a challenging immunosuppressive environment, making it difficult to treat with traditional immunotherapy; currently, sipuleucel-T is the only FDA-approved immunotherapy specifically for prostate cancer, effective mainly for select patients with indolent metastatic castration-resistant prostate cancer.

Future strategies in immuno-oncology for prostate cancer may involve innovative approaches like bispecific antibodies and CAR-T cells targeting specific markers on tumor cells, which could improve patient outcomes by overcoming the immune barriers present in this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refining Immuno-Oncology Approaches in Metastatic Prostate Cancer: Transcending Current Limitations. Wong, RL., Yu, EY.[2022]

Cancer immunotherapy, particularly therapeutic vaccines and immune checkpoint inhibitors, has shown promise in improving overall survival for patients with advanced prostate cancer, with sipuleucel-T being a notable FDA-approved treatment.

The effectiveness of these therapies appears to be linked to their ability to modulate tumor growth rates rather than causing immediate changes in disease progression, suggesting that they may be most beneficial for patients with lower tumor volumes and less aggressive disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic vaccines as a promising treatment modality against prostate cancer: rationale and recent advances. Singh, BH., Gulley, JL.[2021]

Immunotherapy is emerging as a promising treatment for prostate cancer, which is traditionally treated with surgery, radiotherapy, and hormonal therapy, especially for advanced cases where docetaxel-based chemotherapy is FDA-approved and shows significant survival benefits.

Recent developments in prostate cancer immunotherapy, including dendritic cell vaccines and immune checkpoint inhibitors, have shown potential for targeted tumor destruction with less systemic toxicity, although these benefits are still being evaluated in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update: immunological strategies for prostate cancer. Drake, CG., Antonarakis, ES.[2021]

Citations

1. inmunebio.com inmunebio.com/index.php/newsroom/2025-news/muneiosaerialofmuneinetastaticas20250804050503

INmune Bio's CaRe PC Trial of INKmune™ in Metastatic ... INKmune™ is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the US this year. About ...

2. onclive.com onclive.com/view/care-prostate-study-of-inkmune-in-metastatic-crpc-hits-primary-secondary-end-points

CaRe Prostate Study of INKmune in Metastatic CRPC Hits ... “INKmune was safe and effective at activating natural killer cells in a subset of more than half of these patients with advanced disease,” Mark ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06056791

Study of INKmune in Patients With mCRPC (CaRe Prostate) Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data. Measurement of Progression Free Survival (PFS). 2-3 years.

4. cancernetwork.com cancernetwork.com/view/inkmune-exhibits-favorable-safety-in-metastatic-crpc

INKmune Exhibits Favorable Safety in Metastatic CRPC “INKmune was safe and effective at activating NK cells in a subset of more than half of patients with advanced [metastatic CRPC],” Mark Lowdell, ...

5. urologytimes.com urologytimes.com/view/phase-1-2-trial-of-inkmune-therapy-for-mcrpc-meets-primary-end-point

Phase 1/2 trial of INKmune therapy for mCRPC meets ... “INKmune was safe and effective at activating NK cells in a subset of more than half of these patients with advanced disease,” said Mark ...

6. inmunebio.com inmunebio.com/index.php/newsroom/2025-news/muneiopenshaseinighoseohortofmune20250227110228

INmune Bio Opens Phase II in High Dose Cohort ... “INKmune™ can be given to men with mCRPC in an out-patient setting and so far has an exemplary safety profile,” said RJ Tesi, MD CEO of INmune.