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

Primary Purpose

Prostatic Neoplasms

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Tcm+ Goserelin acetate+ Bicalutamide

Tcm+Goserelin acetate+Abiraterone acetate

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring prostate cancer, central memory T cell

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Guangdong Provincial Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

metastatic hormone-sensitive prostate cancer (mHSPC):After diagnosis of mHSPC, patients receive infusions of autologous Tcm cells intravenously on Day 1 and Day 42, followed by hormonal therapy of maximal androgen blockade (LHRH-a + Anti-androgen).

metastatic castration-resistant prostate cancer (mCRPC):After diagnosis of mCRPC, patients receive infusions of autologous Tcm cells intravenously on Day 1 and Day 42, followed by goserelin acetate monthly. Abiraterone acetate 1000 mg orally daily plus prednisone 5 mg orally twice daily will be also administered continuously during the duration of the trial.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Overall survival (OS)

Defined as time from treatment initiation to death

Progression-free survival (PFS)

Defined as the time from treatment initiation to disease progression, relapse or death due to any cause, whichever occurs first

Full Information

NCT ID

NCT03587285

First Posted

July 3, 2018

Last Updated

July 30, 2019

Sponsor

Guangzhou University of Traditional Chinese Medicine

Collaborators

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03587285

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 23, 2018 (Actual)

Primary Completion Date

July 30, 2021 (Anticipated)

Study Completion Date

July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou University of Traditional Chinese Medicine

Collaborators

Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

Keywords

prostate cancer, central memory T cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Tcm+ Goserelin acetate+ Bicalutamide

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Tcm+Goserelin acetate+Abiraterone acetate

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidences of adverse events or serious adverse events (AE and SAE)

Description

This is graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale, version 4.0

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Time to castration-resistance (TCR) in mHSPC patients

Description

Time Frame

2 years

Title

Overall survival (OS)

Description

Defined as time from treatment initiation to death

Time Frame

2 years

Title

Progression-free survival (PFS)

Description

Defined as the time from treatment initiation to disease progression, relapse or death due to any cause, whichever occurs first

Time Frame

2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Songtao Xiang, MD

Organizational Affiliation

Guangzhou University of Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangdong Provincial Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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