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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Carl & Edyth Lindner Center for Research and Education at The Christ Hospital and The Christ Hospital Cancer Center
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Measurement of peripheral blood activated NK cell (memory like NK cell phenotype) percentage by flow cytometry to \>2 times pre-treatment percentage.
Time frame: 2-3 years
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Measurement of Prostate Specific Antigen (PSA) to determine the percent of patients that decrease PSA by ≥30% during treatment.
Time frame: 2-3 years
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Measurement of disease burden as determined by prostate-specific membrane antigen (PMSA) positron emission tomography (PET) scan.
Time frame: 2-3 years
Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC.
Measurement of change in circulating tumor DNA (ctDNA).
Time frame: 2-3 years
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
Measurement of frequency and severity of Dose-Limiting Toxicities (DLT).
Time frame: 2-3 years
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
MTD identification, if available.
Time frame: 2-3 years
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
Measurement of frequency and severity of adverse events (AEs).
Time frame: 2-3 years
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Cincinnati, Ohio, United States
Renovatio Clinical
El Paso, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC.
Measurement of frequency and severity of serious adverse events (SAEs).
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing RECIST.
Assessment based on current Prostate Cancer Working Group 3 (PCWG3) modified Response Evaluation Criteria (RECIST) Version 1.1, where applicable.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.
Measurement of PSA response using PSA50 response rate.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.
Measurement of the period of time PSA decrease by ≥30%.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing PSA.
Measurement of the period of time PSA is below baseline.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data.
Measurement of Progression Free Survival (PFS).
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data.
Measurement of Radiological Progression Free Survival (rPFS).
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing disease response.
Measurement of Objective response rate (ORR)
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing disease response.
Measurement of the Disease control rate.
Time frame: 2-3 years
Evaluate the overall clinical efficacy of INKmune treatment in patients utilizing survival data.
Measurement of Overall survival (OS).
Time frame: 2-3 years