Prostate CancerPhase 1NCT05732948
PD-1 Silent PSMA/PSCA Targeted CAR-T for the Treatment of Prostate Cancer
A Phase 1 study testing autologous T cells & cyclophosphamide in people with Prostate Cancer, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 1 site in China.
Trial summary
This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- autologous T cells & cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2018to 31 Dec 2024
- Phase
- Phase 1
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of metastatic disease in bone on bone scan, CT scan, and/or by MRI atany time following the initial diagnosis of prostate cancer;
- The corresponding antigens such as PSMA and PSCA/PDL1 were highly expressed;
- Male patients aged between 18 and 65;
- Karnofsky score ≥ 60, ECOG≤ 2;
- Important organ function as defined by the following: cardiac ejection fraction ≥ 50%; electrocardiogram showed no obvious abnormalities; creatinine clearance rate calculated by using Cockcroft- Gault formula ≥40ml/min ; ALT/AST≤ 3×the institution normal upper limit; total bilirubin ≤2.0mg/dl; coagulation function: PT/ APPT<2 ×the institution normal upper limit; SpO2 >92%; Blood: hemoglobin>80g/L, ANC ≥ 1, PLT ≥ 50×109/L;
- There is measurable target lesion;
- Voluntary informed consent is given;
Who cannot join
- Immunosuppressive drugs or hormones were used a week before admission;
- Severe active infection;
- Human immunodeficiency virus (HIV) positive;
- Active hepatitis B or C infection;
- Past medical history of other malignancies. Not included: patients who have been cured at any time prior to the treatment of the skin basal or squamous cell carcinoma and cervical carcinoma in situ; the other tumor has not listed above, but has been used and only cured by surgery, without further treatment by other measures, the subjects of disease-free survival more than 5 years, can be included in the study;
- Patients participating in other clinical trials;
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- The researchers thought the subjects were unfit for inclusion or unable to participate in or complete the study;
- Patients with congenital immunodeficiency;
- There is a history of myocardial infarction and serious arrhythmia within six months;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Xiaowen Tang, Ph.D, (0086)51267781856, tangxiaowen@suda.edu.cn
About this study
This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune cells (T cells) used in this study will be the patients own immune cells. They will be removed from the patients blood, changed in the laboratory, and then put back into their body. T cells help the body fight infections. These cells may also kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer cells. For this reason, the physician will change the T cells by putting in a gene so that they may be able to better recognize and kill the prostate cancer cells. A gene is a portion of information which comes from the DNA and tells the cell what to do. This gene will be put into the patients T cells by a weakened virus. It is hoped that this approach will help the T cells recognize the prostate cancer tumor cells and possibly kill them. This is an entirely new treatment for prostate cancer and it is not known if it will have any beneficial or unexpected harmful effects.
Read the detailed description
Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. It has become the fourth tumor treatment model after traditional tumor therapies (surgery, chemotherapy, radiotherapy) . With the development of the research field, the CAR-T cell basis and clinical research of various targets have achieved good results. PSCA, PSMA,RORγ are potential targets and spectacular paradigm in the diagnosis and treatment of prostate cancer. This study is for evaluation of the safety and efficacy of PD-1(programmed death 1)silent PSMA(prostate-specific membrane antigen)/PSCA(prostate stem cell antigen)targeted CAR-T for the Treatment of Castrate Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Being tested
- autologous T cells & cyclophosphamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous T cells & cyclophosphamideDrug
This is a phase I dose escalation study to assess the safety and tolerability using increasing doses of PD-1(programmed death 1)silent PSMA(prostate-specific membrane antigen)/PSCA(prostate stem cell antigen)targeted CAR-T administered one day after pretreatment with cyclophosphamide.
| Study group | Role | What they receive |
|---|---|---|
| autologous T cells & cyclophosphamide | Experimental | This is a phase I dose escalation study to assess the safety and tolerability using increasing doses of engineered autologous T cells PD-1 silent targeted to PSMA/PSMA administered one day after pretreatment with cyclophosphamide. Receives: Drug: autologous T cells & cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response is assessmented with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Dose escalation is based on the dose limiting toxicity (DLT). In this phase I trial, dose escalation will be based on the DLT, defined as a grade 3 or 4 toxicity (excluding alopecia, fatigue) developing after infusion of the T cells as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Scale (CTCAE) Version 3.0. Only toxicities that are possibly, probably, or definitely related to treatment will be considered DLTs. Patients will be observed for DLTs four weeks (28 days) from the T cell infusion
Measured: 8 weeks
Secondary outcomes (1)
Asverse event is evaluated with CTCAE, version 4.0
- Changes in bone metastases [ Time Frame: Week 12 then every 3 months ]
- Changes in biomarkers of bone metastasis and metabolism [ Time Frame: Week 4 and week 12 ]
- Changes in circulating tumor cells [ Time Frame: Weeks 4, 12, 24 and every 3 months ]
- Humoral and cell-mediated immunity to PSMA/PSCA and other known prostate cancer antigens [ Time Frame: Weeks 12 and 24 ]
- To assess patterns of change in PSA. [ Time Frame: 5 years ]
- To track the persistence, accumulation, and migration of genetically retargeted anti-PSMA/PSCA autologous T cells [ Time Frame: 2 years ]
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start2 Aug 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
- Investigators
- Tang Xiaowen, Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732948
- Sponsor's protocol ID
- UCTPSMA-PSCA v1.0
- Status last verified
- Feb 2023
- First submitted
- 5 Aug 2018
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Silent PSMA/PSCA Targeted CAR-T for the Treatment of Prostate Cancer
- ClinicalTrials.gov ID
- NCT05732948
- Acronym / sponsor ID
- UCTPSMA-PSCA v1.0
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Feb 2023 (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.
This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune cells (T cells) used in this study will be the patients own immune cells. They will be removed from the patients blood, changed in the laboratory, and then put back into their body. T cells help the body fight infections. These cells may also kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer cells. For this reason, the physician will change the T cells by putting in a gene so that they may be able to better recognize and kill the prostate cancer cells. A gene is a portion of information which comes from the DNA and tells the cell what to do. This gene will be put into the patients T cells by a weakened virus. It is hoped that this approach will help the T cells recognize the prostate cancer tumor cells and possibly kill them. This is an entirely new treatment for prostate cancer and it is not known if it will have any beneficial or unexpected harmful effects.
Detailed description
Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. It has become the fourth tumor treatment model after traditional tumor therapies (surgery, chemotherapy, radiotherapy) . With the development of the research field, the CAR-T cell basis and clinical research of various targets have achieved good results. PSCA, PSMA,RORγ are potential targets and spectacular paradigm in the diagnosis and treatment of prostate cancer. This study is for evaluation of the safety and efficacy of PD-1(programmed death 1)silent PSMA(prostate-specific membrane antigen)/PSCA(prostate stem cell antigen)targeted CAR-T for the Treatment of Castrate Metastatic 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 T cells & cyclophosphamide | Experimental | Drug: autologous T cells & cyclophosphamideThis is a phase I dose escalation study to assess the safety and tolerability using increasing doses of engineered autologous T cells PD-1 silent targeted to PSMA/PSMA administered one day after pretreatment with cyclophosphamide. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Evidence of metastatic disease in bone on bone scan, CT scan, and/or by MRI atany time following the initial diagnosis of prostate cancer;
- The corresponding antigens such as PSMA and PSCA/PDL1 were highly expressed;
- Male patients aged between 18 and 65;
- Karnofsky score ≥ 60, ECOG≤ 2;
- Important organ function as defined by the following: cardiac ejection fraction ≥ 50%; electrocardiogram showed no obvious abnormalities; creatinine clearance rate calculated by using Cockcroft- Gault formula ≥40ml/min ; ALT/AST≤ 3×the institution normal upper limit; total bilirubin ≤2.0mg/dl; coagulation function: PT/ APPT<2 ×the institution normal upper limit; SpO2 >92%; Blood: hemoglobin>80g/L, ANC ≥ 1, PLT ≥ 50×109/L;
Key exclusion criteria (9 listed)
- Immunosuppressive drugs or hormones were used a week before admission;
- Severe active infection;
- Human immunodeficiency virus (HIV) positive;
- Active hepatitis B or C infection;
- Past medical history of other malignancies. Not included: patients who have been cured at any time prior to the treatment of the skin basal or squamous cell carcinoma and cervical carcinoma in situ; the other tumor has not listed above, but has been used and only cured by surgery, without further treatment by other measures, the subjects of disease-free survival more than 5 years, can be included in the study;
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 T cells & cyclophosphamideThis is a phase I dose escalation study to assess the safety and tolerability using increasing doses of PD-1(programmed death 1)silent PSMA(prostate-specific membrane antigen)/PSCA(prostate stem cell antigen)targeted CAR-T administered one day after pretreatment with cyclophosphamide. | Drug | autologous T cells & cyclophosphamide |
Primary outcome
Tumor response is assessmented with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: 8 weeks
Dose escalation is based on the dose limiting toxicity (DLT). In this phase I trial, dose escalation will be based on the DLT, defined as a grade 3 or 4 toxicity (excluding alopecia, fatigue) developing after infusion of the T cells as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Scale (CTCAE) Version 3.0. Only toxicities that are possibly, probably, or definitely related to treatment will be considered DLTs. Patients will be observed for DLTs four weeks (28 days) from the T cell infusion
1 secondary outcome
Asverse event is evaluated with CTCAE, version 4.0
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Tang Xiaowen study chair
The First Affiliated Hospital of Soochow 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 study testing autologous T cells & cyclophosphamide in people with Prostate Cancer, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,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 7 inclusion and 9 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 29 Nov 2023. 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 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.
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 Tang Xiaowen, Ph.D (（0086）51267781856, tangxiaowen@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response is assessmented with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: 8 weeks). 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 29 Nov 2023.