Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07756593
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sipuleucel-T — BIOLOGICAL
    Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
  • N803 — BIOLOGICAL
    N-803 is a biologic that is administered subcutaneously in the abdominal area.

Study Details

This phase Ib single-center open-label de-escalation study uses a modified 3+3 design to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of standard of care Sip-T and N-803 in patients with metastatic androgen pathway modulation resistant (mAPMR) prostate cancer. Patients will receive treatment for up to 8 weeks.

Key Dates

First listed
Aug 10, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Apr 14, 2029
Completion
Jan 31, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Dose level 0 Starting dose: N-803 + SIP-T
    Patients will receive standard dose (\>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 15 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30.
  • Experimental: Cohort 1: Dose level -1: N-803 + SIP-T
    Patients will receive standard dose (\>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 10 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30.
  • Experimental: Cohort 1: Dose level -2: N-803 + SIP-T
    Patients will receive standard dose (\>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 6 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30.
  • Experimental: Cohort 2: N-803 + SIP-T
    Patients will receive standard dose (\>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and recommended phase 2 dose (RP2D) of N-803 24 hours after SIP-T on Day 2, 16, and 30. An additional dose of N-803 will occur on Day -5 or 5 days before first SIP-T dose.
  • Experimental: Cohort 3: N-803 + SIP-T
    Patients will receive standard dose (\>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and RP2D of N-803 24 hours after SIP-T on Day 2, 16, and 30. An additional dose of N-803 will occur on Day 37.

Primary Outcome Measure

Frequency of dose-limiting toxicities (Cohort 1 only) [ Time Frame: Start of treatment (day 1 dose of Sip-T) through 14 days following the last dose of N-803 (total time up to 44 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Russell K Pachynski, M.D.
[email protected]
314-286-2341
Russell K Pachynski, M.D. (PRINCIPAL_INVESTIGATOR)
Daniel Thorek, Ph.D. (PRINCIPAL_INVESTIGATOR)
John Visconti, D.O. (SUB_INVESTIGATOR)
Melissa Reimers, M.D. (SUB_INVESTIGATOR)
Wilbur Song, M.D. (SUB_INVESTIGATOR)
Eric Knoche, M.D. (SUB_INVESTIGATOR)
Mark Sundermeyer, M.D. (SUB_INVESTIGATOR)
Peter Oppelt, M.D. (SUB_INVESTIGATOR)
Jingqin Rosy Luo, Ph.D. (SUB_INVESTIGATOR)
Jade Tao, Ph.D. (SUB_INVESTIGATOR)

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Washington University School of Medicine· St Louis, MO

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