Clinical trial NCT03085966: Autologous Immune Cell Therapy in Combination With LHRH-a in Patients With mCRPC
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Metastatic Castration-resistant Prostate Cancer
Keywords: central memory T cell
metastatic castration-resistant prostate cancer
Lead sponsor: Shanghai AbelZeta Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Fudan University
First posted: 2017-03-21
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: AE and SAE
timeFrame: 24 months
Secondary outcomes:
measure: OS
timeFrame: 24 months
measure: PFS
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai Shi
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Dingwei Ye
role: PRINCIPAL_INVESTIGATOR
References: