Castrate-Resistant Prostate CancerPhase 1NCT04768608
PD1 Integrated Anti-PSMA CART in Treating Patients With Castrate-Resistant Prostate Cancer
A Phase 1 study testing PD1-PSMA-CART cells in people with Castrate-Resistant Prostate Cancer, run by Zhejiang University at 1 site in China.
Trial summary
PD1-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Castrate-Resistant Prostate Cancer
- What is being tested?
- PD1-PSMA-CART cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2021to 30 May 2023
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand and voluntarily sign informed consent.
- Aged 18 to 75 years old.
- Expected survival > 6 months.
- CRPC patients:Serum testosterone reached castration level (<50ng/dl or<1.7nmol/L) and: prostate specific antigen (PSA) increased more than 50% at intervals of one week or three consecutive times, with PSA>2 ng/ml; or imaging scans revealed two or more new lesions or enlargement of soft tissue lesions that met the criteria for evaluating solid tumor response.
- CRPC patients received abiraterone or chemotherapy for 3 months or more, and were ineffective or progressive (PSA continued to rise for 3 months, or bone scan/whole-body imaging showed local recurrence or new metastasis).
- Immunohistochemical staining of repetitive biopsy tissues showed the expression of PSMA in tumor cells was more than 50%.
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- Eastern Cooperative Oncology Group (ECOG) score ≤2.
- Virological examination was negative.
- Hematological indexes: hemoglobin > 100 g/L, platelet count > 100×10^9/L, absolute neutrophil count > 1.5×10^9/L.
Who cannot join
- Prior treatment with any CART therapy targeting any target.
- Prior treatment with any PSMA targeting therapy.
- Need steroid therapy, except physiological replacement therapy.
- Prior treatment with any immunotherapy, including tumor vaccine therapy, radium-223, checkpoint inhibitors and others.
- Subjects with severe mental disorders.
- Subjects with other malignant tumors.
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- Subjects with severe cardiovascular diseases: a, New York Heart Association (NYHA) stage III or IV congestive heart failure; b, history of myocardial infarction or coronary artery bypass grafting (CABG) within 6 months; c, clinical significance of ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or dehydration; d, history of severe non-ischemic cardiomyopathy; e, the left ventricular ejection fraction (left ventricular ejection fraction< 55%) was decreased by echocardiography or multiple gated acquisition scan (within 8 weeks before peripheral blood mononuclear cell (PBMC) collection), and abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis.
- Patients with ongoing or active infection.
- Organ function: a, Alanine aminotransferase or Aspartate aminotransferase >2.5*Upper limit of normal (ULN); Creatine kinase>1.5*ULN; Creatine kinase isoenzyme >1.5*ULN; Troponin T >1.5*ULN; b, Total bilirubin >1.5*ULN; c, Partial prothrombin time or activated partial thromboplastin time or international standardized ratio > 1.5*ULN without anticoagulant treatment.
- History of participation in other clinical studies within 3 months or treatment with any gene therapy product.
- Intolerant or allergic to cyclophosphamide or fludarabine.
- Subjects not appropriate to participate in this clinical study judged by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: Clinical Trial for the Safety and Efficacy of Non-viral PD1 Integrated Anti-PSMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Castrate-Resistant Prostate Cancer
PD1-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer
Read the detailed description
Clinical trial for the safety and efficacy of Non-viral programmed cell death protein-1(PD1) integrated anti-prostate-specific-membrane-antigen(PSMA) chimeric antigen receptor T(CART) cells in the treatment of Refractory Castrate-Resistant Prostate Cancer(CRPC)
- Conditions
- Castrate-Resistant Prostate Cancer
- Being tested
- PD1-PSMA-CART cells
- Keywords
- Castrate-Resistant Prostate Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD1-PSMA-CART cellsDrug
Also called Non-viral PD1 integrated anti-PSMA chimeric antigen receptor T cell
PD1-PSMA-CART cells will be given IV at split doses
| Study group | Role | What they receive |
|---|---|---|
| PD1-PSMA-CART | Experimental | Patients undergo leukapheresis by receiving cyclophosphamide and fludarabine on days -6 to -4, and then receive PD1-PSMA-CART intravenous injection (IV) at split doses from day 0 on. Receives: Drug: PD1-PSMA-CART cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set.
Measured: 28 days
Secondary outcomes (3)
Prostate specific antigen (PSA) response rate
proportion of patients with ≥50% PSA decline from baseline at any time point after therapy and maintained for ≥4weeks
Measured: 180 days
Radiographic response rate by RECIST 1.1 & PCWG3
Proportion of patients with a best response of either complete response or partial response, assessed using Prostate Cancer Working group3(PCWG3) response criteria \& Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Measured: 180 days
Number of persistent CART cells detected by Quantitative Real-time Polymerase Chain Reaction or flow cytometry
Number of persistent CART cells detected by Quantitative Real-time Polymerase Chain Reaction or flow cytometry
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start23 Dec 2021
- Primary completion30 Jun 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castrate-Resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- Group A: 0.5×10\^6 cells / kg; Group B: 1.0×10\^6 cells / kg; Group C: 2.0×10\^6 cells / kg.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Bioray Laboratories
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
- Investigators
- Weijia Fang, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768608
- Sponsor's protocol ID
- 2020-CAR-00CH2
- Status last verified
- Jul 2023
- First submitted
- 18 Feb 2021
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Safety and Efficacy of Non-viral PD1 Integrated Anti-PSMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Castrate-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04768608
- Acronym / sponsor ID
- 2020-CAR-00CH2
- Conditions
- Castrate-Resistant Prostate Cancer
- Keywords
- Castrate-Resistant Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Bioray Laboratories
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 24 Feb 2021 (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.
PD1-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer
Detailed description
Clinical trial for the safety and efficacy of Non-viral programmed cell death protein-1(PD1) integrated anti-prostate-specific-membrane-antigen(PSMA) chimeric antigen receptor T(CART) cells in the treatment of Refractory Castrate-Resistant Prostate Cancer(CRPC)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Group A: 0.5×10^6 cells / kg; Group B: 1.0×10^6 cells / kg; Group C: 2.0×10^6 cells / kg.
| Arm | Type | Receives |
|---|---|---|
| PD1-PSMA-CART | Experimental | Drug: PD1-PSMA-CART cellsPatients undergo leukapheresis by receiving cyclophosphamide and fludarabine on days -6 to -4, and then receive PD1-PSMA-CART intravenous injection (IV) at split doses from day 0 on. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fully understand and voluntarily sign informed consent.
- Aged 18 to 75 years old.
- Expected survival > 6 months.
- CRPC patients:Serum testosterone reached castration level (<50ng/dl or<1.7nmol/L) and: prostate specific antigen (PSA) increased more than 50% at intervals of one week or three consecutive times, with PSA>2 ng/ml; or imaging scans revealed two or more new lesions or enlargement of soft tissue lesions that met the criteria for evaluating solid tumor response.
- CRPC patients received abiraterone or chemotherapy for 3 months or more, and were ineffective or progressive (PSA continued to rise for 3 months, or bone scan/whole-body imaging showed local recurrence or new metastasis).
Key exclusion criteria (12 listed)
- Prior treatment with any CART therapy targeting any target.
- Prior treatment with any PSMA targeting therapy.
- Need steroid therapy, except physiological replacement therapy.
- Prior treatment with any immunotherapy, including tumor vaccine therapy, radium-223, checkpoint inhibitors and others.
- Subjects with severe mental disorders.
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 |
|---|---|---|
| PD1-PSMA-CART cellsAlso: Non-viral PD1 integrated anti-PSMA chimeric antigen receptor T cellPD1-PSMA-CART cells will be given IV at split doses | Drug | PD1-PSMA-CART |
Primary outcome
Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
Time frame: 28 days
All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set.
3 secondary outcomes
Prostate specific antigen (PSA) response rate
Time frame: 180 days
Radiographic response rate by RECIST 1.1 & PCWG3
Time frame: 180 days
Number of persistent CART cells detected by Quantitative Real-time Polymerase Chain Reaction or flow cytometry
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
Related trials for Castrate-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
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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.
Weijia Fang, MD principal investigator
First Affiliated Hospital of Zhejiang 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 PD1-PSMA-CART cells in people with Castrate-Resistant Prostate Cancer, run by Zhejiang University 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 9 inclusion and 12 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: finished, as of the sponsor's last update on 17 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (time frame: 28 days). 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 17 Jul 2023.