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Cancer Vaccine

INKmune for Prostate Cancer (CaRe Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Inmune Bio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

viii. Bilirubin < 1.5x ULN (< 3x ULN in Gilbert's Syndrome). ix. Creatinine clearance/estimated GFR ≥ 50 mL/min (MDRD or Cockcroft-Gault). x. Resting room air PaO2 saturation of >95% as measured by pulse oximetry.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment called INKmune in men with advanced prostate cancer. INKmune is given to patients through a vein in three separate doses, with at least one week in

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects of INKmune are not listed here, but common ones for similar immune therapies may include flu-like symptoms, fatigue, fever, chills, weakness, nausea or vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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I have advanced prostate cancer that has worsened despite hormone therapy and up to three other treatments.

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I am fully active or can carry out light work.

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My prostate cancer is confirmed to be adenocarcinoma.

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I am a man over 18 years old.

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My testosterone levels are below 50 ng/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

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

Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing disease response.

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Other study objectives

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

Assess the experience of clinical trial participation by patients through a comprehensive patient survey provided post visit at 3 timepoints during the trial.

Complete transcriptomic analyses from optional biopsy tissue and previously resected tissue (if available).

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3: 5 x 10^8 INKmuneExperimental Treatment1 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 INKmuneExperimental Treatment1 Intervention

Group III: Cohort 1: 1 x 10^8 INKmuneExperimental Treatment1 Intervention

0 / 6Eligibility criteria met