A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03587285
• Other study ID #: S2017-05-01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 23, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: July 2019
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility, safety and oncological efficacy of hormonal therapy combined with autologous Tcm cells for patients with advanced prostate cancer.

Description:

Adoptive cancer immunotherapy,the infusion of tumor-reactive T cells to patients,represents a promising approach for the treatment of advanced metastatic disease.It has been shown that central memory T cells (Tcm) were the optimal antitumor T cells for adoptive cell transfer in cancer patients.However,the potential of autologous Tcm cells to treat the advanced prostate cancer has not been evaluated.

This is an open-label pilot study to determine if the infusion of autologous Tcm cells combined with hormonal therapy is safe and effective for the treatment of advanced prostate cancer.This study will have the following two cohorts:Cohort A) metastatic hormone-sensitive prostate cancer (mHSPC) treated with maximal androgen blockade plus autologous Tcm cells and Cohort B) metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate plus autologous Tcm cells.A total of 60 evaluable subjects will be enrolled over an enrollment period of 24 months.The study is planned to enroll approximately 30 evaluable subjects in each treatment cohort.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: July 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subjects who understand and sign the consent form for this study

• Males age =18 years

• Subjects diagnosed with metastatic hormone-sensitive prostate cancers (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Expected survival time of at least 24 months

• Adequate hematologic, renal, and liver function: WBC greater than 3.5 x 109/L; Absolute neutrophils count greater than 1.5 x 109/L; Platelet count greater than 80 x 109/L; Hemoglobin at least 90g/L; AST less than 2 x upper limit of normal (ULN); Creatinine less than 1.5 x ULN

• No obvious abnormalities in the electrocardiogram

Exclusion Criteria:

• Clinically significant cardiovascular disease: New York Heart Association (NYHA) class III or IV chronic congestive heart failure, coronary heart disease (myocardial infarction within 6 months); cardiac arrhythmia requiring anti-arrhythmic drug (beta-blocker or digoxin is allowed to be used); uncontrolled high blood pressure

• HIV infection

• Acute exacerbation of chronic hepatitis A or hepatitis B infection

• The subject has uncontrollable seizures required pharmacotherapy (such as steroids or antiepileptic drugs)

• The subject has a history of allogeneic organ transplants

• Subject with irregular hemorrhagic disease

• The subject receives dialysis treatment The subject has a history of other malignant tumor except subjects with curable basal cell carcinoma, superficial bladder tumor or other tumors has been cured over three years of study entry

• The subject has a history of gastrointestinal hemorrhage within 30 days of study entry

• The subject has an allergic history or is allergic to the drug in this study

• The subject has serious diseases of respiratory, nervous or mental system

• Subject with immune disease, auto-immune disease requires systemic ongoing immunosuppressive therapy

• The subject has problems with drug or alcohol abuse

• Major surgery within 4 weeks of enrollment

• Prior autologous bone marrow transplantation within 4 weeks of enrollment

• The subject has participated in any other therapeutic clinical trial with an experimental drug in the 4 weeks prior to this trial

• The subject has any other unsuitable or adverse condition to be determined by the investigator

• Any medical intervention or any circumstances that could compromise the safety and compliance of the trial subjects

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Biological:
• Tcm+ Goserelin acetate+ Bicalutamide
Autologous Tcm cells administered intravenously on Day 1 and Day 42,3.6mg goserelin acetate injection administered subcutaneously monthly,50 mg bicalutamide administered orally daily
• Tcm+Goserelin acetate+Abiraterone acetate
Tcm cells administered intravenously on Day 1 and Day 42,3.6mg goserelin acetate injection administered subcutaneously monthly,1000 mg abiraterone acetate administered orally daily plus 5 mg prednisone administered orally twice daily

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine	Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidences of adverse events or serious adverse events (AE and SAE)	This is graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale, version 4.0	2 years
Secondary	Time to castration-resistance (TCR) in mHSPC patients	Defined as the time from treatment initiation to the first castration-resistant event (radiographic disease progression, prostate-specific antigen (PSA) progression or the occurrence of the first symptomatic skeletal event), whichever occurs first	2 years
Secondary	Overall survival (OS)	Defined as time from treatment initiation to death	2 years
Secondary	Progression-free survival (PFS)	Defined as the time from treatment initiation to disease progression, relapse or death due to any cause, whichever occurs first	2 years