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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03085966
• Other study ID #: MNWK2016-08-04
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 9, 2017
• Last updated: March 15, 2017
• Start date: February 27, 2017
• Est. completion date: December 27, 2019

Study information

• Verified date: March 2017
• Source: Cellular Biomedicine Group Ltd.
• Contact: Dingwei Ye
• Email: dwyeli[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 27, 2019
• Est. primary completion date: October 27, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• autologous immune cell therapy
Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells)

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai Shi	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Cellular Biomedicine Group Ltd.	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE and SAE	Incidences of adverse events or serious adverse events	24 months
Secondary	OS	Overall survival	24 months
Secondary	PFS	Progression-Free Survival	24 months