AzTrials
AzTrials

Prostate Cancer Castration-resistant Prostate CancerEarly Phase 1NCT07298239

An Exploratory Clinical Study Evaluating the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy for Metastatic Castration-resistant Prostate Cancer (mCRPC)

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study introduces a new treatment approach for metastatic castration-resistant prostate cancer, a stage of disease that remains difficult to manage with current therapies. Prostate cancer is the second most common cancer in men worldwide, and many patients eventually progress to an advanced, treatment-resistant… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
anti-PSMA CAR-NK
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
18 Dec 2025to 1 Apr 2028
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

  • Age ≥ 18 years, male;
  • Diagnosis of metastatic castration-resistant prostate cancer (mCRPC) meeting the following criteria: ① Serum testosterone at castration level: < 50 ng/dL or < 1.7 nmol/L; ② Meeting any one of the following conditions: a. PSA progression: Three consecutive rises in PSA measured at intervals of at least 1 week, with two increases being ≥ 50% above the PSA nadir, and a PSA value > 2 ng/mL; b. Radiographic progression: Two or more new lesions detected on bone scan, or an increase in soft tissue lesions assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST).
  • Expected survival ≥ 6 months;
  • ECOG performance status of 0-2;
  • Positive prostate-specific membrane antigen (PSMA) expression;
  • Voluntarily participate, provide written informed consent, and be able to comply with follow-up.

Who cannot join

  • Prior treatment with other cell therapy products besides the investigational product, such as dendritic cells (DC), cytokine-induced killer cells (CIK), T cells, natural killer cells (NK), chimeric antigen receptor T-cell immunotherapy (CAR-T), etc.;
  • History of other malignancies within 5 years prior to screening (except for completely resolved carcinoma in situ or malignancies deemed by the investigator to be slow-progressing);
  • Abnormal function of major organs: a. Absolute 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 × the upper limit of normal (ULN) (or ≥ 5 × ULN for subjects with liver metastases); c. Renal function: Serum creatinine (Cr) ≥ 1.5 × ULN; d. Coagulation function: Prothrombin time (PT), Activated partial thromboplastin time (APTT), International Normalized Ratio (INR) ≥ 1.5 × ULN;
  • Any currently treated active (viral, bacterial, fungal) infection, or any infection within the past 6 weeks requiring intravenous antibiotics for 7 days or longer, or any active infection requiring oral antibiotics within the past week;
  • Active autoimmune disease, or history of severe autoimmune disease requiring long-term immunosuppressive therapy;
  • Participation in another clinical trial study within 3 months;
Show all 10Show fewer
  • Inability to employ effective contraceptive measures;
  • History of hypersensitivity to biologic macromolecular drugs;
  • Untreated chronic active hepatitis B, or chronic hepatitis B virus carriers with HBV DNA ≥ 1000 copies/mL, or patients with active hepatitis C;
  • Subjects deemed by the investigator to be unsuitable for participation in this study for other reasons.

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

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 不限, 100000

    sujun Han Han, 010-67781331, cancergcp@163.com

    Recruiting

Other trials in China

About this study

Official title: A Single-Center, Open-Label, Single-Arm, Exploratory Clinical Study to Evaluate the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

This study introduces a new treatment approach for metastatic castration-resistant prostate cancer, a stage of disease that remains difficult to manage with current therapies. Prostate cancer is the second most common cancer in men worldwide, and many patients eventually progress to an advanced, treatment-resistant stage despite hormone therapy, newer hormonal agents, or chemotherapy. Patients with metastatic castration-resistant disease often face a poor prognosis, complications such as bone metastases, and significant impacts on quality of life, highlighting the urgent need for new treatment options. This research focuses on an innovative immunotherapy using allogeneic anti-PSMA CAR-NK cells, which are engineered natural killer cells designed to precisely recognize and kill prostate cancer cells expressing the prostate-specific membrane antigen. CAR-NK cells combine the natural tumor-killing ability of NK cells with enhanced targeting and reduced immune escape, offering a potentially safer and more effective strategy. Through this clinical study, the safety, tolerability, and preliminary effectiveness of anti-PSMA CAR-NK cell therapy will be evaluated, aiming to provide new evidence and expand future treatment possibilities for patients with advanced prostate cancer.

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 groups in NCT07298239
Study groupRoleWhat they receive
Experimental groupExperimentalNot described
Receives: Biological: anti-PSMA CAR-NK

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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: Day-2-Day-1、Day0、Day2、Day7、Day9、Day14、Day16、Day21、Day28、Day60 and Day90 post infusion

  2. 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、Day0、Day1、Day2、Day7、Day8、Day9、Day14、Day15、Day16、Day21、Day28、Day60、Day90、Day120、Day180、Day270 and Day360

  3. The proportion of patients with a decrease in PSA levels from baseline

    PSA response rate

    Measured: Baseline toDay0、Day1、Day2、Day7、Day8、Day9、Day14、Day15、Day16、Day21、Day28、Day60、Day90、Day120、Day180、Day270 and Day360 post infusion

  4. Progression-free survival (PFS) after Anti-PSMA CAR NK Cell infusion

    Survival time of patients

    Measured: Baseline to 1 year post infusion

  5. Time to clinical progression

    The time from baseline to the appearance of increased PSA levels or imaging progression.

    Measured: Baseline to Day28、Day90、Day180、Day270 and Day360 post infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2025
  2. Study start18 Dec 2025
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07298239
Sponsor's protocol ID
25/216-0216
Status last verified
Nov 2025
First submitted
24 Nov 2025
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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 6 inclusion and 10 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 22 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?

On the ClinicalTrials.gov record for NCT07298239.

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 22 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in