Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer
6 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
30
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Russell K Pachynski, M.D.
- Numéro de téléphone: 314-286-2341
- E-mail: rkpachynski@wustl.edu
Lieux d'étude
-
-
Missouri
-
St Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
-
Sous-enquêteur:
- Jingqin Rosy Luo, Ph.D.
-
Contact:
- Russell K Pachynski, M.D.
- Numéro de téléphone: 314-286-2341
- E-mail: rkpachynski@wustl.edu
-
Chercheur principal:
- Russell K Pachynski, M.D.
-
Sous-enquêteur:
- Peter Oppelt, M.D.
-
Sous-enquêteur:
- Eric Knoche, M.D.
-
Sous-enquêteur:
- Melissa Reimers, M.D.
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Sous-enquêteur:
- Jade Tao, Ph.D.
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Sous-enquêteur:
- Mark Sundermeyer, M.D.
-
Chercheur principal:
- Daniel Thorek, Ph.D.
-
Sous-enquêteur:
- John Visconti, D.O.
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Sous-enquêteur:
- Wilbur Song, M.D.
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Expérimental: 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.
Autres noms:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Expérimental: 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.
Autres noms:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Expérimental: 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.
Autres noms:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Expérimental: 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.
Autres noms:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Frequency of dose-limiting toxicities (Cohort 1 only)
Délai: 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)
Délai: 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
Délai: 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)
|
|
|
Number and type of adverse events measured via CTCAE v6.0
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PSA30 Response
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Through completion of follow-up (up to 26 months)
|
Through completion of follow-up (up to 26 months)
|
|
|
Overall survival (OS)
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Russell K Pachynski, M.D., Washington University School of Medicine
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
30 novembre 2026
Achèvement primaire (Estimé)
14 avril 2029
Achèvement de l'étude (Estimé)
31 janvier 2031
Dates d'inscription aux études
Première soumission
6 août 2026
Première soumission répondant aux critères de contrôle qualité
6 août 2026
Première publication (Réel)
10 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 26-x147
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified individual participant data that underlie the results reported will be available for investigators with approval by an independent review committee.
Délai de partage IPD
Data will be made available beginning 9 months and ending 36 months following publication.
Critères d'accès au partage IPD
Investigators who have approval to use the data by an independent review committee.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Oui
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