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Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer.

NCT06765954 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-05-05

No results posted yet for this study

Summary

This study tests a new treatment for men with high-risk prostate cancer who can't have surgery. The treatment combines three experimental drugs and radiation therapy. Researchers will track how well the treatment works and how safe it is. The study will last about five years.

Conditions

  • High-risk Prostate Cancer

Interventions

DRUG

ETBX-071 (PSA-based Oncolytic Virus)

Administered subcutaneously (SC) before and after radiation therapy. The specific dosing schedule varies slightly depending on the cohort.

DRUG

M-CENK (Activated NK Cells)

Administered intravenously (IV) before and after radiation therapy, also with variations in the timing and dosing across different cohorts.

RADIATION

External Beam Radiation Therapy (EBRT)

This is a standard treatment administered to all participants. The specific dose and schedule (40 Gy in 5 fractions over 2 weeks or up to 9 weeks) are determined by the investigator based on clinical judgment.

RADIATION

Androgen Deprivation Therapy (ADT)

May be used in conjunction with the other therapies. The specific type and duration of ADT are at the investigator's discretion, and it may be initiated up to 6 months after the completion of radiotherapy. This treatment is not part of the experimental treatment regimen.

RADIATION

Post-radiation immunotherapy

The post-radiation immunotherapy phase in the ResQ110B-PROS study involves the continued administration of N-803, ETBX-071, and M-CENK, but with a specific schedule and after the completion of radiation therapy.

DRUG

N-803 (IL-15 Superagonist)

Administered subcutaneously (SC) both before and after radiation therapy. The specific dosing schedule varies slightly depending on the cohort.

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce Brown · ImmunityBio, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2031-01-31
Completion
2031-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06765954 on ClinicalTrials.gov