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

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

Study Overview

• Status: Unknown
• Conditions: Metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Biological: autologous immune cell therapy

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai Shi, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Dingwei Ye; Email: dwyeli@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: autologous immune cell therapy; Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells)	Biological: autologous immune cell therapy; Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE and SAE	Incidences of adverse events or serious adverse events	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	24 months
PFS	Progression-Free Survival	24 months

Collaborators and Investigators

• Sponsor: Cellular Biomedicine Group Ltd.
• Collaborators: Fudan University
• Investigators: Principal Investigator: Dingwei Ye, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Anticipated): October 27, 2019
• Study Completion (Anticipated): December 27, 2019

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: metastatic castration-resistant prostate cancer; central memory T cell
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: MNWK2016-08-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No