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Metastatic Castration-resistant Prostate CancerEarly Phase 1NCT06228404

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

A Early Phase 1 study testing Enhanced autologous PSMA-CAR T in people with Metastatic Castration-resistant 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 one center, single-arm, open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer, and the sample size is set to 7-18 subjects. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
What is being tested?
Enhanced autologous PSMA-CAR T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
3 Mar 2024to 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 to 75 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 18-75 years;
  • expected survival of more than 6 months;
  • metastatic castration-resistant prostate adenocarcinoma (CRPC) patients.
  • Receiving CRPC standard treatment (such as new endocrine therapy, chemotherapy and radium-223, etc., one or more of the combination therapy) after the diagnosis of CRPC, ineffective or progressive disease (PSA continued to rise 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;
  • 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 × 109/L; c. neutrophils > 1.5 × 109/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 > 2.5ULN; CK > ULN; CK-MB > ULN; TnT > 1.5ULN; b. total bilirubin > 1.5ULN; c. partial prothrombin time or activated partial thromboplastin time or international normalized ratio > 1.5ULN 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 and 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 Enhanced Autologous PSMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Castration Resistant Prostate Cancer

This is one center, single-arm, open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer, and the sample size is set to 7-18 subjects.

Read the detailed description

This is one center, single-arm, open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer, and the sample size is set to 7-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C). Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group before entering the phase II study.

Being tested
Enhanced autologous PSMA-CAR T
Keywords
Castration-resistant Prostate Cancer, Metastasis, Prostate-Specific Membrane Antigen, Chimeric Antigen Receptor T cell, Refractory Castration-resistant Prostate Cancer
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • Enhanced autologous PSMA-CAR TDrug

    3 escalated dosing cohorts are designed to explore safety and efficacy of enhanced autologous PSMA-CAR T:

    cohort A： CART-PSMA cells 0.25×106/kgBW, following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given according to protocol;

    cohort B： CART-PSMA cells 0.75×106/kgBW，following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given according to protocol;

    cohort C： CART-PSMA cells 2×106/kgBW，following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given according to protocol;

Study groups in NCT06228404
Study groupRoleWhat they receive
Enhanced autologous PSMA-CAR T:ExperimentalEnhanced autologous PSMA-CAR T is an electrotransfer system based on non-viral transposons that integrates the CAR gene into the genome of host cells by electrotransfer using PMSA as a target, while this CAR vector co-expresses enhanced factors and plays a strong regulatory role in innate and adaptive immunity.
Receives: Drug: Enhanced autologous PSMA-CAR T

What is being measured

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

  1. DLT

    The number and severity of dose-limiting toxicity (DLT) events

    Measured: Within 28 Days After Enhanced autologous PSMA-CAR T Infusion

  2. 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

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

    Safety assessment: toxicity profile

    Measured: Through 6 months after CAR-T cell infusion

Secondary outcomes (5)

  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: 3 months after CAR-T cell infusion

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

    With the day of the first infusion of the cellular preparation recorded as DO, 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 CAR-T infusion.

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

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

    With the day of the first infusion of the cellular preparation recorded as DO, 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 AUCO-28 at 28 days and area under the curve AUCO-90 at 90 days);

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

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

    Pharmacokinetic (PD) endpoints is assessed by changes in serum cytokine levels (eg.IL-6) after CAR-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 posted29 Jan 2024
  2. Study start3 Mar 2024
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
A：0.25×106/kgBW B: 0.75×106/kgBW C: 2×106/kgBW
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06228404
Sponsor's protocol ID
2022-BRL-501
Status last verified
Jul 2026
First submitted
19 Jan 2024
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Enhanced autologous PSMA-CAR T in people with Metastatic Castration-resistant 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 8 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?

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?

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?

DLT (time frame: Within 28 Days After Enhanced autologous PSMA-CAR T 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 NCT06228404.

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.

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