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

NCT ID: NCT03085966

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2019-12-27

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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

autologous immune cell therapy

Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells)

Group Type: EXPERIMENTAL

autologous immune cell therapy

Intervention Type: BIOLOGICAL

Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells)

Interventions

autologous immune cell therapy

Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Shanghai AbelZeta Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dingwei Ye

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai Shi, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dingwei Ye

Role: CONTACT

dwyeli@163.com

Facility Contacts

Dingwei Ye

Role: primary

dwyeli@163.com

Other Identifiers

MNWK2016-08-04

Identifier Type: -

Identifier Source: org_study_id