Autologous Immune Cell Therapy in Combination With LHRH-a in Patients With mCRPC

Phase 1

• Conditions: Metastatic Castration-resistant Prostate Cancer
• Interventions: Biological: autologous immune cell therapy

• Registration Number: NCT03085966
• Lead Sponsor: Shanghai AbelZeta Ltd.

Brief Summary

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

Detailed Description

Autologous dendritic cells (DC) are known to activate other immune cells, such as central memory T cells (Tcm cells), that are able to mount an attack against cancer cells. The purpose of this study is to evaluate the feasibility, safety and efficacy of patients' own immune cells combined with the luteinizing hormone releasing hormone agonists (LHRH-a) for treatment of metastatic castration-resistant prostate cancer.

Study Timeline

• Study Start: 2017-02-27
• Status Verified: 2017-03
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-15
• Last Update Submitted: 2017-03-15
• Study First Posted: 2017-03-21
• Last Update Posted: 2017-03-21
• Primary Completion: 2019-10-27
• Study Completion: 2019-12-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous immune cell therapy	autologous immune cell therapy	Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells)

Primary Outcome Measures

Name	Time	Method
AE and SAE	24 months	Incidences of adverse events or serious adverse events

Secondary Outcome Measures

Name	Time	Method
OS	24 months	Overall survival
PFS	24 months	Progression-Free Survival

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai Shi, Shanghai, China