Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer
6. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
30
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Russell K Pachynski, M.D.
- Telefonní číslo: 314-286-2341
- E-mail: rkpachynski@wustl.edu
Studijní místa
-
-
Missouri
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St Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
-
Dílčí vyšetřovatel:
- Jingqin Rosy Luo, Ph.D.
-
Kontakt:
- Russell K Pachynski, M.D.
- Telefonní číslo: 314-286-2341
- E-mail: rkpachynski@wustl.edu
-
Vrchní vyšetřovatel:
- Russell K Pachynski, M.D.
-
Dílčí vyšetřovatel:
- Peter Oppelt, M.D.
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Dílčí vyšetřovatel:
- Eric Knoche, M.D.
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Dílčí vyšetřovatel:
- Melissa Reimers, M.D.
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Dílčí vyšetřovatel:
- Jade Tao, Ph.D.
-
Dílčí vyšetřovatel:
- Mark Sundermeyer, M.D.
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Vrchní vyšetřovatel:
- Daniel Thorek, Ph.D.
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Dílčí vyšetřovatel:
- John Visconti, D.O.
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Dílčí vyšetřovatel:
- Wilbur Song, M.D.
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Experimentální: 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.
Ostatní jména:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Experimentální: 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.
Ostatní jména:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Experimentální: 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.
Ostatní jména:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Experimentální: 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.
Ostatní jména:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Frequency of dose-limiting toxicities (Cohort 1 only)
Časové okno: 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.
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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)
|
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Recommended Phase II Dose (RP2D) (Cohort 1 only)
Časové okno: 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.
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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)
|
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Number of severe (grade 3+) adverse events measured via CTCAE v6.0
Časové okno: Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
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Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
|
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Number and type of adverse events measured via CTCAE v6.0
Časové okno: Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
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Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
PSA30 Response
Časové okno: 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)
|
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PSA50 Response
Časové okno: 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.
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Start of treatment to completion of follow-up (up to 26 months)
|
|
PSA90 Response
Časové okno: 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)
Časové okno: 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.
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Start of treatment to date of progression or death or last follow-up (up to 26 months)
|
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Failure-free survival (FFS)
Časové okno: Start of treatment to date of any progression events or last follow-up (up to 26 months)
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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
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Start of treatment to date of any progression events or last follow-up (up to 26 months)
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Time to next therapy (TTNT)
Časové okno: Through completion of follow-up (up to 26 months)
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Through completion of follow-up (up to 26 months)
|
|
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Overall survival (OS)
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Russell K Pachynski, M.D., Washington University School of Medicine
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
30. listopadu 2026
Primární dokončení (Odhadovaný)
14. dubna 2029
Dokončení studie (Odhadovaný)
31. ledna 2031
Termíny zápisu do studia
První předloženo
6. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
6. srpna 2026
První zveřejněno (Aktuální)
10. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
10. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
6. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
De-identified individual participant data that underlie the results reported will be available for investigators with approval by an independent review committee.
Časový rámec sdílení IPD
Data will be made available beginning 9 months and ending 36 months following publication.
Kritéria přístupu pro sdílení IPD
Investigators who have approval to use the data by an independent review committee.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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produkt vyrobený a vyvážený z USA
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .