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

NCT03085966 | Unknown Phase 1

• 1 other identifier: MNWK2016-08-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

central memory T cell; metastatic castration-resistant prostate cancer

Outcome Measures

Primary Outcomes (1)

• AE and SAE

  Incidences of adverse events or serious adverse events

  24 months

Secondary Outcomes (2)

• OS

  24 months

• PFS

  24 months

Study Arms (1)

autologous immune cell therapy

EXPERIMENTAL

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

Biological: autologous immune cell therapy

Interventions

autologous immune cell therapy BIOLOGICAL

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

autologous immune cell therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai AbelZeta Ltd.: lead
• Fudan University: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai Shi, Shanghai Municipality, 200032, China

RECRUITING

Study Officials

• Dingwei Ye

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dingwei Ye

CONTACT

dwyeli@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 21, 2017
• Study Start: February 27, 2017
• Primary Completion: October 27, 2019
• Study Completion: December 27, 2019
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

CN (1)