Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-04 @ 4:12 PM
Study NCT ID:
NCT06765902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-04
First Post:
2024-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy Before and After Surgery
Sponsor:
ImmunityBio, Inc.
Organization:
Study Overview
Official Title:
Open-Label, Phase 2 Clinical Trial of Pre-Surgery and Post-Surgery Immunotherapy With N-803, ETBX-071, and M-CENK in Combination With Surgery for Participants With High-Risk Prostate Cancer Pre-Prostatectomy.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-12
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:
None
Brief Summary:
This Phase 2 clinical trial is testing a new immunotherapy combination (N-803, ETBX-071, M-CENK) for men with high-risk prostate cancer before and after prostate surgery. The goal is to see if this treatment improves cancer outcomes and is safe.
Detailed Description:
This study is an open-label, Phase 2 clinical trial investigating the efficacy and safety of a three-part immunotherapy regimen in combination with surgery for men with high-risk prostate cancer who have not yet undergone a prostatectomy. The immunotherapy consists of three components:
N-803 (Nogapendekin Alfa Inbakicept): A soluble complex consisting of a modified human interleukin-15 (IL-15) variant bound to a human IL-15 receptor alpha subunit/human immunoglobulin G (IgG) Fc fusion protein. N-803 acts as a growth and activation factor for natural killer (NK) cells and effector and memory T-cells, enhancing their ability to kill cancer cells and stimulate an immune response. It is administered subcutaneously.
ETBX-071 (hAd5 \[E1-, E2b-, E3-\]-PSA Vaccine): A replication-defective human adenovirus serotype 5 vector modified to encode human prostate-specific antigen (PSA). This vaccine is designed to induce a cell-mediated immune response against PSA-expressing prostate cancer cells. It is administered subcutaneously.
M-CENK (Autologous Memory Cytokine-Enriched NK Cells): These are the patient's own NK cells that are collected through apheresis, expanded and activated ex vivo using cytokines (IL-12, IL-15, and IL-18) to enhance their cytotoxicity and IFN-γ production. The resulting M-CENK cells are then infused intravenously.
Study Design:
The study involves three main phases:
Pre-surgery Immunotherapy: Participants receive N-803, ETBX-071, and M-CENK according to a specific schedule for six weeks before undergoing prostatectomy.
Surgery: Participants undergo a radical prostatectomy.
Post-surgery Immunotherapy: Following surgery, participants receive four cycles of the same immunotherapy regimen (N-803, ETBX-071, and M-CENK) over a 24-week period. Some participants may also receive external beam radiation therapy (EBRT) post-surgery at the discretion of the investigator.
Endpoints:
The study will assess several endpoints, including:
Primary Endpoints: Event-free survival (EFS) and biochemical recurrence-free survival (bRFS) are the main measures of the treatment's effectiveness in preventing cancer recurrence.
Secondary Endpoints: These include the rate of PSA reduction within six months post-surgery and safety assessments (adverse events, serious adverse events, changes in vital signs and laboratory tests).
Exploratory Endpoints: These are additional measures to assess quality of life, sexual function, immune responses, and changes in the tumor microenvironment.
Patient Selection:
The study includes men with high-risk prostate cancer, defined by specific criteria related to PSA levels, Gleason score, and tumor stage. Participants must meet specific inclusion criteria and cannot have certain pre-existing conditions or prior treatments that might interfere with the study.
Follow-up:
Participants will be followed for up to five years after completing the treatment, with regular monitoring and assessments.
This detailed description provides a more comprehensive overview of the study's design, methodology, and objectives.
N-803 (Nogapendekin Alfa Inbakicept): A soluble complex consisting of a modified human interleukin-15 (IL-15) variant bound to a human IL-15 receptor alpha subunit/human immunoglobulin G (IgG) Fc fusion protein. N-803 acts as a growth and activation factor for natural killer (NK) cells and effector and memory T-cells, enhancing their ability to kill cancer cells and stimulate an immune response. It is administered subcutaneously.
ETBX-071 (hAd5 \[E1-, E2b-, E3-\]-PSA Vaccine): A replication-defective human adenovirus serotype 5 vector modified to encode human prostate-specific antigen (PSA). This vaccine is designed to induce a cell-mediated immune response against PSA-expressing prostate cancer cells. It is administered subcutaneously.
M-CENK (Autologous Memory Cytokine-Enriched NK Cells): These are the patient's own NK cells that are collected through apheresis, expanded and activated ex vivo using cytokines (IL-12, IL-15, and IL-18) to enhance their cytotoxicity and IFN-γ production. The resulting M-CENK cells are then infused intravenously.
Study Design:
The study involves three main phases:
Pre-surgery Immunotherapy: Participants receive N-803, ETBX-071, and M-CENK according to a specific schedule for six weeks before undergoing prostatectomy.
Surgery: Participants undergo a radical prostatectomy.
Post-surgery Immunotherapy: Following surgery, participants receive four cycles of the same immunotherapy regimen (N-803, ETBX-071, and M-CENK) over a 24-week period. Some participants may also receive external beam radiation therapy (EBRT) post-surgery at the discretion of the investigator.
Endpoints:
The study will assess several endpoints, including:
Primary Endpoints: Event-free survival (EFS) and biochemical recurrence-free survival (bRFS) are the main measures of the treatment's effectiveness in preventing cancer recurrence.
Secondary Endpoints: These include the rate of PSA reduction within six months post-surgery and safety assessments (adverse events, serious adverse events, changes in vital signs and laboratory tests).
Exploratory Endpoints: These are additional measures to assess quality of life, sexual function, immune responses, and changes in the tumor microenvironment.
Patient Selection:
The study includes men with high-risk prostate cancer, defined by specific criteria related to PSA levels, Gleason score, and tumor stage. Participants must meet specific inclusion criteria and cannot have certain pre-existing conditions or prior treatments that might interfere with the study.
Follow-up:
Participants will be followed for up to five years after completing the treatment, with regular monitoring and assessments.
This detailed description provides a more comprehensive overview of the study's design, methodology, and objectives.
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?: