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Metastatic Prostate CancerPhase 1NCT06895811

Clinical Study of Safety and Efficacy of Universal PSMA CAR- T in Refractory CRPC

A Phase 1 study testing PSMA-UCAR T (BRL-302) in people with Metastatic Prostate Cancer and Castration-resistant Prostate Cancer, run by Shanghai Changzheng Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single-arm, single-center, open-label clinical trial designed to evaluate the clinical safety and tolerability of different doses of Prostate-Specific Membrane Antigen (PSMA)-Universal Chimeric Antigen Receptor (UCAR) T-lymphocytes (PSMA-UCAR T) for the treatment of patients with refractory… Read more about this study

Who is it for?
Ages 18 to 80 years, men only
What is being tested?
PSMA-UCAR T (BRL-302)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteChina
Study dates
27 Mar 2025to Nov 2026
Phase
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 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully understood and voluntarily signed informed consent for this study;
  • Male, aged 18-80 years;
  • Expected survival of more than 6 months;
  • Metastatic castration-resistant prostate adenocarcinoma (CRPC) patients:
  • Have received CRPC standard treatment (such as novel hormone therapies, chemotherapy and radium-223, etc., one or more of the combination therapy) after the diagnosis of CRPC, and is ineffective or progressive :PSA continued rising for 3 months, or bone scan/whole-body MRI/PET-CT showed local recurrence or new metastatic lesions, demonstrating disease progression;
  • PSMA expression in tumor cells was positive in immunohistochemical staining of prostate/metastatic biopsy tissue before enrollment (within 6 months prior to enrollment);
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  • ECOG score < 2 ;
  • Virological examination HAV (hepatitis A virus), HBV (hepatitis B virus), HCV (hepatitis C virus), HIV (human immunodeficiency virus), TP (Treponema pallidum) quantitative detection was negative, (antigen and antibody screening method unknown, confirmed by nucleic acid method);
  • Hematological parameters met the following criteria: a. hemoglobin > 100 g/L; b. platelet count > 100 × 10^9/L; c. neutrophils > 1.5 × 10^9/L.

Who cannot join

  • Subjects meeting any of the following exclusion criteria will be excluded:
  • Have received any previous treatment with CAR-T therapy ;
  • Have received any previous treatment that targets PSMA;
  • Tumor pathology suggests a special type of prostate cancer (e.g., neuroendocrine prostate cancer, etc.)
  • Severe mental disorders;
  • Suffered from previous malignancies, except for the following: a. basal cell carcinoma or squamous cell carcinoma after standardized treatment; b. having a primary malignancy, but completely resected, with a complete remission time of ≥ 5 years.
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  • Subjects with severe cardiovascular disease; a.New York Heart Association (NYHA) stage III or IV congestive heart failure; b.Myocardial infarction ≤ 6 months prior to enrollment or coronary artery bypass graft (CABG); c.Clinically significant ventricular arrhythmia, or history of unexplained syncope, nonvasovagal or not due to dehydration; d.History of severe non-ischemic cardiomyopathy; e.Decreased left ventricular ejection fraction (LVEF < 55%) as assessed by echocardiogram or multigated acquisition (MUGA) scan, abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis;
  • Active infectious disease or any major infectious event requiring high grade antibiotics;
  • Organ function in the following abnormalities: a. serum aspartate aminotransferase or alanine aminotransferase > 2.5*Upper Limit of Normal (ULN); CK > ULN; CK-MB > ULN; TnT > 1.5*ULN; b. total bilirubin > 1.5*ULN; c. partial prothrombin time or activated partial thromboplastin time or international normalized ratio > 1.5*ULN in the absence of anticoagulant therapy;
  • Participation in other clinical studies in the past three months or previous treatment with any gene therapy product;
  • Intolerance or hypersensitivity to cyclophosphamide or fludarabine chemotherapy;
  • Unsuitability to participate in this clinical study in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changzheng hospital

    Shanghai, Shanghai Municipality, 201109

Other trials in China

About this study

Official title: The Safety and Efficacy Evaluation of Universal PSMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Castration Resistant Prostate Cancer

This is a single-arm, single-center, open-label clinical trial designed to evaluate the clinical safety and tolerability of different doses of Prostate-Specific Membrane Antigen (PSMA)-Universal Chimeric Antigen Receptor (UCAR) T-lymphocytes (PSMA-UCAR T) for the treatment of patients with refractory castration-resistant prostate cancer (CRPC).

Read the detailed description

This is a single-arm, single-center, open-label clinical trial, which aims to evaluate safety and clinical efficacy of different doses of PSMA-UCAR T (BRL-302) in treating patients with refractory CRPC.

Three patients will be firstly enrolled at a dose level (DL) of 5.0 × 10^6cells/kg in the DL1 group. Based on preliminary safety data, efficacy information, and PK/PD parameters obtained at DL1 cohort, the investigator may enroll another three patients in a decreased dose level group of DL-2: 3 × 10^6 cells/kg or DL-1:1 × 10^6 cells/ kg, after thorough discussions between the investigators.

Being tested
PSMA-UCAR T (BRL-302)
Keywords
Prostate cancer, Universal CAR-T, Metastatic Castration-resistant Prostate Cancer, Chimeric Antigen Receptor T cell
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PSMA-UCAR T (BRL-302)Biological

    Three patients will be firstly enrolled at a dose level (DL) of 5.0 × 10^6cells/kg in the DL1 group, following lymphodepleting chemotherapy which will be given under instruction of protocol and investigators' assessment;

    Based on preliminary safety data, efficacy information, and PK/PD parameters obtained at DL1 cohort, the investigator may enroll another three patients in a decreased dose level group of DL-2: 3 × 10^6 cells/kg or DL-1:1 × 10^6 cells/ kg, after thorough discussions between the investigators.

Study groups in NCT06895811
Study groupRoleWhat they receive
PSMA-UCAR T (BRL-302)ExperimentalNot described
Receives: Biological: PSMA-UCAR T (BRL-302)

What is being measured

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

  1. The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE V5.0)

    Safety assessment: toxicity profile

    Measured: Through 6 months after CAR T cell infusion

  2. Cytokine Release Syndrome (CRS) grading post CAR T cell infusion.

    Safety assessment: toxicity profile

    Measured: Through 6 months after CAR T cell infusion

  3. Safety assessment: dose-limiting toxicity

    Incidence of dose-limiting toxicity (DLT) within 28 days. Dose-limiting toxicity (DLT) is defined as any relevant adverse event that ≥ grade 3 and did not resolve to a grade ≤ grade 2 within 28 days after the first infusion back.

    Measured: 28 days after CAR T cell infusion

Secondary outcomes (6)

  1. Efficacy assessment: PSA changes

    Prostate-Specific Antigen (PSA) changes assessed by serum PSA measurement (ng/ml).

    Measured: 6 months after CAR T cell infusion

  2. Efficacy assessment: radiographic Progression-Free Survival (rPFS)

    rPFS is defined as the time between treatment with study drug and the development of imaging progression or death from any cause, whichever occurs first, with imaging progression encompassing the evaluation of progression of primary lesions, non-regional lymph node invasion, soft tissue metastases, and bone metastatic lesions according to RECIST 1.1 and PCWG3 criteria.

    Measured: 6 months after CAR T cell infusion

  3. 6-months Progression-Free Survival (PFS)

    PFS is defined as the time between treatment with study drug and disease progression or death from any cause, whichever occurs first, including biochemical progression or radiographic progression after evaluation according to RECIST 1.1 and PCWG3 criteria according to the included.

    Measured: 6 months after CAR T cell infusion

  4. Pharmacokinetics (PK) assessment: expansion of CAR T cells

    With the day of the first infusion of the cellular preparation recorded as D0, the monitoring phase of the pharmacokinetic study started from 1 day before the first infusion (D-1).

    Expansion of CAR T cells will be assessed by concentration profile of CAR-T cells in peripheral blood after PSMA-UCAR T infusion.

    Measured: From Day 1 till at least 3 months after CAR T cell infusion

  5. Pharmacokinetics (PK) assessment: persistence of CAR T cells

    With the day of the first infusion of the cellular preparation recorded as D0, the monitoring phase of the pharmacokinetic study started from 1 day before the first infusion (D-1).

    Persistence of CAR T cells will be assessed by T-cell survival time (area under the curve AUC0-28 at 28 days and area under the curve AUC0-90 at 90 days);

    Measured: From Day 1 till at least 3 months after CAR T cell infusion

  6. Pharmacodynamics (PD) assessment eg. (Level of IL-6)

    Pharmacokinetic (PD) endpoints is assessed by changes in serum cytokine levels (eg.IL-6) after PSMA-UCAR T infusion.

    Measured: From Day 1 till at least 3 months after CAR T cell infusion

Timeline

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

  1. First posted26 Mar 2025
  2. Study start27 Mar 2025
  3. Primary completionJul 2026 (estimated)
  4. Study completionNov 2026 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06895811
Sponsor's protocol ID
2022-BRL-302
Status last verified
Jul 2026
First submitted
12 Nov 2024
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PSMA-UCAR T (BRL-302) in people with Metastatic Prostate Cancer and Castration-resistant Prostate Cancer, run by Shanghai Changzheng Hospital 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 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?

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?

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?

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?

The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE V5.0) (time frame: Through 6 months after CAR T cell infusion). The study lists 3 primary outcomes in all. 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 NCT06895811.

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 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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