Prostate Cancer Castration-resistant Prostate CancerEarly Phase 1NCT07156045
Study of Allogeneic Anti-PSMA CAR-NK Cell for Metastatic Castration-Resistant Prostate Cancer
A Early Phase 1 study testing anti-PSMA CAR-NK in people with Prostate Cancer Castration-resistant Prostate Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
At present, no cell drug with an indication for mCRPC has been approved for marketing in China, and there is no scholar to fight against it PSMA-CAR-NK cell therapy CRPC was reported in a study. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Castration-resistant Prostate Cancer
- What is being tested?
- anti-PSMA CAR-NK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To enter the trial, subjects had to meet all of the following eligibility criteria:
- diagnosed metastatic castration-resistant prostate cancer (mCRPC);
- Castration level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L);
- Positive expression of PSMA;
- According to the definition of CRPC in the Guidelines for the Diagnosis and Treatment of Prostate Cancer (2022 edition), the disease still progresses after castration and meets any of the following criteria:
- A.According to the increase in PSA level, there should be 3 consecutive increases in PSA at least 1 week apart (the increase in PSA is more than 50% of the minimum value, and PSA > 2 ng/mL); B.Progression of bone disease as defined by PCWG3, defined as the presence of 2 or more new lesions on bone scan; C.CT or MRI results suggested measurable metastasis (lymph node short diameter > 15 mm was defined as lymph node metastasis as assessed by RECIST 1.1);
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- Expected survival time ≥6 months;
- Toxicity of any previous treatment had recovered to ≤ grade 1 at the time of enrollment (except hair loss and hearing loss);
- ECOG score of patients 0-2;
- Patients voluntarily participated and signed the informed consent, and followed the trial treatment plan and visit plan.
Who cannot join
- Subjects who meet one of the following conditions will not be enrolled in the trial:
- Previous recipients of other cell therapy products, such as dendritic cells (DC), multiple cytokine-induced killer cells (CIK), T cells, natural killer cells (NK), chimeric antigen receptor T-cell immunotherapy (CAR-T), etc.;
- Patients with a history of biological macromolecule drug allergy;
- Abnormal function of major organs:
- Neutrophil count (ANC) < 1.5×109/L; Platelet count (Plt) < 100×109/L; Hemoglobin (Hb) < 9 g/dL; B. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥2.5×ULN (≥5×ULN for liver metastases); C. Renal function: serum creatinine (Cr) ≥1.5×ULN; D. Prothrombin time (PT) > 15 s, activated partial thrombin time (APTT) was prolonged or shortened by more than 10 s (normal reference value 23 s-37 s), or international normalized ratio (INR) > 1.7; E. Pulmonary function: Severe respiratory diseases (active pulmonary tuberculosis, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
- Previous treatment with any PSMA-targeted therapy;
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- active autoimmune diseases (including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis) or need long-term immunosuppressive therapy of severe autoimmune disease (screening clinic within six weeks before any immunosuppressive therapy), or by the researchers determine in 3 months will be recurrence of subjects;
- have had other malignancies other than prostate cancer (other than basal or squamous cell skin cancer) in the past 5 years that are currently clinically significant and require intervention;
- Any active (viral, bacterial, fungal) infection currently being treated or any infection requiring intravenous antibiotics for 7 or more days or intervals during the past 6 weeks or any active infection requiring oral antibiotics during the past 1 week;
- untreated chronic active hepatitis B, or chronic hepatitis B virus carriers with HBV DNA≥1000 copies /mL, or active hepatitis C patients;
- Patients who have participated in other clinical trials and used study drugs within 3 months;
- Effective contraceptive measures cannot be adopted ;
- In the opinion of the investigator, there are other factors that are not suitable for inclusion or affect the participant's participation or completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
sujun Han Han, 010-67781331, cancergcp@163.com
About this study
Official title: Clinical Study on the Safety and Efficacy of Anti-PSMA CAR NK Cells in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
At present, no cell drug with an indication for mCRPC has been approved for marketing in China, and there is no scholar to fight against it PSMA-CAR-NK cell therapy CRPC was reported in a study. Based on the previous basic research, our company has developed CAR-NK cell injection, hoping to further evaluate its safety, tolerability and preliminary efficacy in the treatment of mCRPC patients in clinical studies, and provide new possibilities for the selection of clinical treatment strategies
- Being tested
- anti-PSMA CAR-NK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-PSMA CAR-NKBiological
Targeting PSMA CAR-NK cells
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Biological: anti-PSMA CAR-NK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment related adverse events as assessed by CTCAE v5.0
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Measured: Baseline to 1 year post infusion
Secondary outcomes (5)
The pharmacokinetic analysis of Anti-PSMA CAR-NK Cell
Changes in the number of CD56+/ CD3 Anti-PSMA CAR-NK Cell in peripheral blood over time
Measured: D0, D1, D3, D7, D8, D10, D14, D15, D17, D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
The pharmacodynamics analysis of Anti-PSMA CAR NK Cell
Changes of total prostate specific antigen (tPSA) and free prostate specific antigen (fPSA) in peripheral blood
Measured: Baseline to infusion date, D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7
The proportion of patients with a decrease in PSA levels from baseline
PSA response rate
Measured: Baseline to D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
Progression-free survival (PFS) after Anti-PSMA CAR NK Cell infusion
Survival time of patients
Measured: Baseline to 1 year post infusion
Time to clinical progression
The time from baseline to the appearance of increased PSA levels or imaging progression.
Measured: Baseline to D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XINGNIANZENG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156045
- Sponsor's protocol ID
- 25/062-0062
- Status last verified
- Sep 2025
- First submitted
- 7 Aug 2025
- Last updated
- 23 Jan 2026
- 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Anti-PSMA CAR NK Cells in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT07156045
- Acronym / sponsor ID
- 25/062-0062
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Sep 2025 (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.
At present, no cell drug with an indication for mCRPC has been approved for marketing in China, and there is no scholar to fight against it PSMA-CAR-NK cell therapy CRPC was reported in a study. Based on the previous basic research, our company has developed CAR-NK cell injection, hoping to further evaluate its safety, tolerability and preliminary efficacy in the treatment of mCRPC patients in clinical studies, and provide new possibilities for the selection of clinical treatment strategies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: anti-PSMA CAR-NK |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- diagnosed metastatic castration-resistant prostate cancer (mCRPC);
- Castration level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L);
- Positive expression of PSMA;
- According to the definition of CRPC in the Guidelines for the Diagnosis and Treatment of Prostate Cancer (2022 edition), the disease still progresses after castration and meets any of the following criteria:
- A.According to the increase in PSA level, there should be 3 consecutive increases in PSA at least 1 week apart (the increase in PSA is more than 50% of the minimum value, and PSA > 2 ng/mL); B.Progression of bone disease as defined by PCWG3, defined as the presence of 2 or more new lesions on bone scan; C.CT or MRI results suggested measurable metastasis (lymph node short diameter > 15 mm was defined as lymph node metastasis as assessed by RECIST 1.1);
Key exclusion criteria (13 listed)
- Previous recipients of other cell therapy products, such as dendritic cells (DC), multiple cytokine-induced killer cells (CIK), T cells, natural killer cells (NK), chimeric antigen receptor T-cell immunotherapy (CAR-T), etc.;
- Patients with a history of biological macromolecule drug allergy;
- Abnormal function of major organs:
- Previous treatment with any PSMA-targeted therapy;
- active autoimmune diseases (including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis) or need long-term immunosuppressive therapy of severe autoimmune disease (screening clinic within six weeks before any immunosuppressive therapy), or by the researchers determine in 3 months will be recurrence of subjects;
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 |
|---|---|---|
| anti-PSMA CAR-NKTargeting PSMA CAR-NK cells | Biological | Experimental group |
Primary outcome
Occurrence of treatment related adverse events as assessed by CTCAE v5.0
Time frame: Baseline to 1 year post infusion
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
5 secondary outcomes
The pharmacokinetic analysis of Anti-PSMA CAR-NK Cell
Time frame: D0, D1, D3, D7, D8, D10, D14, D15, D17, D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
The pharmacodynamics analysis of Anti-PSMA CAR NK Cell
Time frame: Baseline to infusion date, D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7
The proportion of patients with a decrease in PSA levels from baseline
Time frame: Baseline to D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
Progression-free survival (PFS) after Anti-PSMA CAR NK Cell infusion
Time frame: Baseline to 1 year post infusion
Time to clinical progression
Time frame: Baseline to D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-PSMA CAR-NK in people with Prostate Cancer Castration-resistant Prostate Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment related adverse events as assessed by CTCAE v5.0 (time frame: Baseline to 1 year post infusion). 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 23 Jan 2026.