Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer
6. august 2026 oppdatert av: Washington University School of Medicine
A Phase Ib Study Evaluating the Safety and Tolerability of Sipuleucel-T (Sip-T) in Combination With N-803 in Patients With Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Russell K Pachynski, M.D.
- Telefonnummer: 314-286-2341
- E-post: rkpachynski@wustl.edu
Studiesteder
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
-
Underetterforsker:
- Jingqin Rosy Luo, Ph.D.
-
Ta kontakt med:
- Russell K Pachynski, M.D.
- Telefonnummer: 314-286-2341
- E-post: rkpachynski@wustl.edu
-
Hovedetterforsker:
- Russell K Pachynski, M.D.
-
Underetterforsker:
- Peter Oppelt, M.D.
-
Underetterforsker:
- Eric Knoche, M.D.
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Underetterforsker:
- Melissa Reimers, M.D.
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Underetterforsker:
- Jade Tao, Ph.D.
-
Underetterforsker:
- Mark Sundermeyer, M.D.
-
Hovedetterforsker:
- Daniel Thorek, Ph.D.
-
Underetterforsker:
- John Visconti, D.O.
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Underetterforsker:
- Wilbur Song, M.D.
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Imaging- or biopsy-proven metastatic disease. May have any type or location of metastases (bone, lymph node, visceral).
- Prior treatment must include either orchiectomy or luteinizing hormone-releasing agonist or antagonist treatment with documented testosterone ≤ 50 ng/dL.
- Eligible for standard of care Sipuleucel-T.
- Recovery to baseline or ≤ grade 1 from toxicities related to any prior treatments, unless AEs are clinically nonsignificant and/or stable on supportive therapy.
- At least 18 years of age.
- ECOG performance status ≤ 2
Adequate bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500 K/cumm without granulocyte colony-stimulating factor support
- Platelets ≥ 100,000 K/cumm without transfusion
- Hemoglobin ≥ 10.0 g/dL
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT) and ALT(SGPT) ≤ 2.5 x IULN
- Calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault
- PSA ≤ 200 ng/mL.
- Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Exclusion Criteria:
- Rapidly progressing disease or symptomatic prostate cancer as assessed by the investigator.
- Prior immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) within the 6 months prior to enrollment.
- Prior systemic radiotherapy (such as Ra-223, Lu177-PSMA) within the 6 months prior to enrollment. Prior palliative radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment is allowed. Prior definitive radiation therapy for localized prostate cancer is allowed.
- Prior exposure to Sipuleucel-T.
- Ongoing systemic immune suppression (oral steroids equivalent to 10 mg daily prednisone or less are allowed; topical, inhaled, and intra-articular steroids are allowed).
- Currently receiving any other investigational therapeutic or imaging agents.
- Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or N-803 or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
- HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
- Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
- History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
- Uncontrolled infection with hepatitis A.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
Andre navn:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Eksperimentell: 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.
|
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
Andre navn:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Eksperimentell: 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.
|
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
Andre navn:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Eksperimentell: 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.
|
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
Andre navn:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Eksperimentell: 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.
|
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
Andre navn:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of dose-limiting toxicities (Cohort 1 only)
Tidsramme: 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)
|
As assessed via CTCAE v6.0.
Dose limiting toxicities will be evaluated according to protocol.
|
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)
|
|
Recommended Phase II Dose (RP2D) (Cohort 1 only)
Tidsramme: Start of treatment (day 1 dose of Sip-T) through 14 days following the last dose of N-803 for all participants in Cohort 1 (total time up to 44 days)
|
RP2D is defined as the highest dose of N-803 that has an overall DLT rate of less than 33% in total of 6 patients.
|
Start of treatment (day 1 dose of Sip-T) through 14 days following the last dose of N-803 for all participants in Cohort 1 (total time up to 44 days)
|
|
Number of severe (grade 3+) adverse events measured via CTCAE v6.0
Tidsramme: Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
|
Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
|
|
|
Number and type of adverse events measured via CTCAE v6.0
Tidsramme: Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
|
Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
PSA30 Response
Tidsramme: Start of treatment to completion of follow-up (up to 26 months)
|
PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 30% reduction in PSA level from baseline measured twice at least 3 weeks apart.
PSA response is measured per PCWG3 criteria.
|
Start of treatment to completion of follow-up (up to 26 months)
|
|
PSA50 Response
Tidsramme: Start of treatment to completion of follow-up (up to 26 months)
|
PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 50% reduction in PSA level from baseline measured twice at least 3 weeks apart.
PSA response is measured per PCWG3 criteria.
|
Start of treatment to completion of follow-up (up to 26 months)
|
|
PSA90 Response
Tidsramme: Start of treatment to completion of follow-up (up to 26 months)
|
PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 90% reduction in PSA level from baseline measured twice at least 3 weeks apart.
PSA response is measured per PCWG3 criteria.
|
Start of treatment to completion of follow-up (up to 26 months)
|
|
Radiographic progression-free survival (PFS)
Tidsramme: Start of treatment to date of progression or death or last follow-up (up to 26 months)
|
rPFS is defined as the duration of time from start of treatment to time of radiographic progression by PCWG3 or time of death or last follow-up, the event that occurs first.
Patients who have not experienced either event at the time of analysis will be censored at their last radiographic scan date.
All radiographic response criteria are assessed per PCWG3 criteria.
|
Start of treatment to date of progression or death or last follow-up (up to 26 months)
|
|
Failure-free survival (FFS)
Tidsramme: Start of treatment to date of any progression events or last follow-up (up to 26 months)
|
Failure-free survival which is defined from date of treatment start to date of any progression events (radiographic progression, biochemical recurrence, or death, whichever is earlier) or date of last follow-up if experiencing no events
|
Start of treatment to date of any progression events or last follow-up (up to 26 months)
|
|
Time to next therapy (TTNT)
Tidsramme: Through completion of follow-up (up to 26 months)
|
Through completion of follow-up (up to 26 months)
|
|
|
Overall survival (OS)
Tidsramme: Start of treatment to death or last follow-up (up to 26 months)
|
Overall survival is defined as the date of treatment start to date of death or date of last follow-up.
|
Start of treatment to death or last follow-up (up to 26 months)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Russell K Pachynski, M.D., Washington University School of Medicine
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. november 2026
Primær fullføring (Antatt)
14. april 2029
Studiet fullført (Antatt)
31. januar 2031
Datoer for studieregistrering
Først innsendt
6. august 2026
Først innsendt som oppfylte QC-kriteriene
6. august 2026
Først lagt ut (Faktiske)
10. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-x147
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data that underlie the results reported will be available for investigators with approval by an independent review committee.
IPD-delingstidsramme
Data will be made available beginning 9 months and ending 36 months following publication.
Tilgangskriterier for IPD-deling
Investigators who have approval to use the data by an independent review committee.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .