Metastatic Castration-resistant Prostate CancerPhase 1/2NCT03085966
Autologous Immune Cell Therapy in Combination With LHRH-a in Patients With mCRPC
A Phase 1/2 study testing autologous immune cell therapy in people with Metastatic Castration-resistant Prostate Cancer, run by Shanghai AbelZeta Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- autologous immune cell therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2017to 27 Dec 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
Who cannot join
- 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；
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Dingwei Ye contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai Shi, Shanghai Municipality, 200032
Dingwei Ye, dwyeli@163.com
About this study
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 of autologous immune cell therapy in combination with the luteinizing hormone releasing hormone agonists (LHRH-a) in patients with metastatic castration-resistant prostate cancer
Read the 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.
- Being tested
- autologous immune cell therapy
- Keywords
- central memory T cell, metastatic castration-resistant prostate cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous immune cell therapyBiological
Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells)
| Study group | Role | What they receive |
|---|---|---|
| autologous immune cell therapy | Experimental | Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells) Receives: Biological: autologous immune cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE and SAE
Incidences of adverse events or serious adverse events
Measured: 24 months
Secondary outcomes (2)
OS
Overall survival
Measured: 24 months
PFS
Progression-Free Survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start27 Feb 2017
- Primary completion27 Oct 2019 (estimated)
- Study completion27 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai AbelZeta Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Dingwei Ye, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085966
- Sponsor's protocol ID
- MNWK2016-08-04
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03085966
- Acronym / sponsor ID
- MNWK2016-08-04
- Keywords
- central memory T cell, metastatic castration-resistant prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai AbelZeta Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 27 Oct 2019 (estimated)
- Study completion
- 27 Dec 2019 (estimated)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous immune cell therapy | Experimental | Biological: autologous immune cell therapyLuteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)；
Key exclusion criteria (15 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous immune cell therapyLuteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells) | Biological | autologous immune cell therapy |
Primary outcome
AE and SAE
Time frame: 24 months
Incidences of adverse events or serious adverse events
2 secondary outcomes
OS
Time frame: 24 months
PFS
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dingwei Ye contact
Dingwei Ye principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing autologous immune cell therapy in people with Metastatic Castration-resistant Prostate Cancer, run by Shanghai AbelZeta Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dingwei Ye (dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE and SAE (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.