Clinical trial · Interventional
Therapeutic Vaccine Plus PD-1 Knockout in Prostate Cancer Treatment
Clinical Assessment of a Therapeutic Vaccine in Combination With PD-1 Knockout T Cells in the Treatment of Prostate Cancer
NCT03525652CI-TRIAL-00032937unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the safety and efficacy of a therapeutic vaccine in combination with PD-1 knockout T cells in the treatment of advanced prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 Knockout T Cells | Biological | — | UNRESOLVED |
| Therapeutic vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Therapeutic vaccine
- description
- Therapeutic vaccine will be prepared ex vivo using the peripheral mononuclear cells from the patients and the vaccine (as maturated dendritic cells) will be infused back to the patients in 3 times with a 2-week interval.
- interventionNames
- Biological: Therapeutic vaccine
- type
- EXPERIMENTAL
- label
- Therapeutic vaccine plus PD-1 knockout
- description
- Therapeutic vaccine and PD-1 knockout T cells will be prepared ex vivo using the white cells from the patients and the vaccine (as maturated dendritic cells) and maturated PD-1 knockout T cells will be infused back to the patients in 3 times.
- interventionNames
- Biological: Therapeutic vaccine
- Biological: PD-1 Knockout T Cells
- type
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * • Histologically confirmed prostate cancer (stage IV, according to NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer, Version 2.2017) * Evidence of metastasis in the soft tissue and/or bone. * Progressive androgen independent castrate resistant prostate cancer. * Serum PSA ≥ 5.0 ng/mL * Estimated life expectancy ≥ 6 months. * Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration. * Adequate hematologic, renal and liver function. Exclusion Criteria: * • Presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites. * Presence of moderate to severe pain treating with opioid analgesics within 21 days prior to registration. * ECOG score ≥ 2. * Any other systemic therapy for prostate cancer (except for medical castration). * Participation in previous study using Provenge (Sipuleucel-T) or similar product. * Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography \> 50%) or spinal cord compression. * Known malignancies other than prostate cancer requiring active treatment within 6 months. * A requirement for systemic immunosuppressive therapy for any reason. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to this product or granulocyte-macrophage colony-stimulating factor. * Any infection requiring parenteral antibiotic therapy or causing fever (temp \> 100.5°F or \> 38.1°C) within 1 week prior to registration. * Any medical intervention or other condition which, in the opinion of the Principal Investigator could compromise adherence with study requirements or otherwise compromise the study's objectives. * Treatment with any of the following medications or interventions within 28 days of registration: Systemic use of corticosteroids, External beam radiation therapy or surgery, Use of non-steroidal antiandrogens Dietary and herbal supplements, as well as alternative treatments that have evidence of hormonal and/or anticancer properties (e.g., prostate cancer (PC) -SPES or PC-SPEC) and saw palmetto, Megestrol acetate (Megace®), diethylstilbesterol (DES), or cyproterone acetate, ++Ketoconazole, 5-alpha-reductase inhibitors, Treatment with any other investigational product Treatment with chemotherapy High dose calcitriol \[1,25(OH)2Vitamin D\] (i.e., \> 0.5 mcg/day). Initiation or discontinuation of bisphosphonate therapy
References
Publications (0)
Data not yet available
No reference posted for this study.