Clinical trial · Interventional
Autologous Immune Cell Therapy in Combination With LHRH-a in Patients With mCRPC
Study of Autologous Immune Cell Therapy in Combination With the Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) in Patients With Metastatic Castration-resistant Prostate Cancer
NCT03085966CI-TRIAL-00026531unknownPhase 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)
Study of autologous immune cell therapy in combination with the luteinizing hormone releasing hormone agonists (LHRH-a) in patients with metastatic castration-resistant 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 |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous immune cell therapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- autologous immune cell therapy
- description
- Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells)
- interventionNames
- Biological: autologous immune cell therapy
Primary outcomes (1)
- measure
- AE and SAE
- timeFrame
- 24 months
- description
- Incidences of adverse events or serious adverse events
Secondary outcomes (2)
- measure
- OS
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Males age ≥ 18 years; * Subjects who understand and sign the consent form for this study; * Metastatic, castrate resistant, histologically confirmed prostate cancer; * PSA\> 5ng / ml; * Serum testosterone ≤ 17nmol / L (50ng / dl); * Expected survival time of at least 24 months; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Subjects did not receive chemotherapy, radiation therapy, surgery and other treatment within 4 weeks; Exclusion Criteria: * The subject has an allergic history of medicine or food; * The patient with more serious heart disease, including but not limited to myocardial infarction, cardiomyopathy, valvular disease, malignant arrhythmia; * Hb \<9.0 g / 100ml, WBC \<3 ×10\^9/ L, LY \<1.0 x10\^9/ L, platelet \<100,000 / mm3; * Patients with immune disease or auto-immune disease (such as Multiple sclerosis, systemic lupus erythematosus,rheumatoid arthritis and inflammatory bowel disease, vitiligo ); * The subject has uncontrolled or hard-to-control diseases of liver, or kidney system; * Patient with visceral metastases, pathological fractures, spinal cord compression symptoms; * Severe pain associated with bone metastases (VAS score ≧ 4 points); * Patient has received immunotherapy (including but not limited to PD-1 / PDL-1, etc.); * patient with irregular hemorrhagic disease; * Subject is HIV, hepatitis B virus, hepatitis C virus, Treponema pallidum infection; * Subject has uncontrollable seizures, or because of mental loss of self-knowledge and so on; * The subject has an history of other malignant tumor; * The patient had drug abuse, drug abuse, and long history of alcoholism in the 12 years prior to this trial; * The subject has participated in any other clinical trial in the 3 months prior to this trial; * The subject has any other unsuitable or adverse condition to be determined by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.