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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

January 31, 2031

Study Completion Date

June 30, 2031

Conditions
High-risk Prostate Cancer
Interventions
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.

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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ImmunityBio, Inc.

INDUSTRY

NCT06765954 - Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer. | Biotech Hunter | Biotech Hunter