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Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06056791
Study type Interventional
Source Inmune Bio, Inc.
Contact Nicole Kay-Mindick
Phone 386 852 2361
Email nmindick@inmunebio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date November 30, 2023
Completion date November 30, 2025

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