Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06056791
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-08-07
Brief Title:
Study of INKmune in Patients With mCRPC CaRe Prostate
Sponsor:
Inmune Bio Inc
Organization:
Inmune Bio Inc
Study Overview
Official Title:
An Open-label Phase IIIa 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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaRe
Brief Summary:
This is an open-label phase IIIa 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
Detailed Description:
This is an open-label phase IIIa 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 1x108 3x108 and 5x108 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
Dose escalation exploring dose levels of 1x108 3x108 and 5x108 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None