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Prostate CancerPhase 1NCT05656573

CART-PSMA Cells for Advanced Prostate Cancer

A Phase 1 study testing CART-PSMA cells in people with Prostate Cancer, run by Nova Therapeutics LLC 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
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Trial summary

This is a single center, open-label phase 1 study to assess the safety and feasibility of PSMA-specific CAR modified autologous T cells (CART-PSMA cells) in patients with advanced prostate cancer. Read more about this study

Who is it for?
Ages 35 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
CART-PSMA cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Mar 2023to 1 Dec 2025
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 35 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All participants must have the ability to understand and the willingness to sign a written informed consent.
  • Histologic confirmation of prostate cancer.
  • Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
  • Under general air conditions, blood oxygen saturation >90%.
  • Adequate liver function, specifically alanine aminotransferase (ALT) < 3 times of upper limit of normal (ULN), aspartate transferase (AST)< 3 times of ULN, serum bilirubin and alkaline phosphatase < 2 times of ULN.
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  • Adequate renal function, specifically serum creatinine < 2.0 mg/dl.
  • Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%.
  • Hemoglobin concentration ≥80g/L.
  • The side effects brought by the latest treatment should be recovered, and the latest chemotherapy should be at least 7 days before; At least three t½ have passed since the latest immunotherapy.

Who cannot join

  • Patients with other malignant tumors or major diseases.
  • Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy.
  • Patients with uncontrolled active infection.
  • Patients with active hepatitis B or hepatitis C infection.
  • Patients with human immunodeficiency virus (HIV) infection.
  • Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).
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  • Patients with various types of serious heart disease or a history of severe cerebrovascular disease.
  • Patients with congenital immune deficiency diseases or bone marrow deficiency diseases.
  • Patients with active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy.
  • Patients with active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS (cytokine release syndrome) or CAR Neurotoxicity.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jay Zhang, MD/PhD contact

858-205-4558

jiezhang8@hotmail.com

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing

    Jay Zhang, MD/PhD

    Xu Zhang, MD/PhD

    Recruiting

Other trials in China

About this study

Official title: Phase I Study of CART-PSMA Cells in Patients With Advanced Prostate Cancer

This is a single center, open-label phase 1 study to assess the safety and feasibility of PSMA-specific CAR modified autologous T cells (CART-PSMA cells) in patients with advanced prostate cancer.

Read the detailed description

Part A (Dose Escalation) + Part B (Expansion Cohort) total up to 20 patients enrolled.

Conditions
Prostate Cancer
Being tested
CART-PSMA cells
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • CART-PSMA cellsDrug

    Also called No other names

    This study consists of 2 parts:

    Part A (Dose Escalation): The investigators are looking the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects in participants that advanced prostate cancer.

    Part B (Expansion Cohort): Participants will be treated at the respective dose (at or below the Maximum Tolerated Dose), as determined during Part A (Dose Escalation).

    Up to 4 dosing cohorts, with up to 3 subjects enrolled in each cohort, will be explored as follows:

    Cohort 1： CART-PSMA cells 1-3x10^7/M^2 (body surface area); Cohort 2： CART-PSMA cells 1-3x10^8/M^2 (body surface area); Cohort 3： Lymphodepletion chemotherapy + CART-PSMA cells 1-3x10^7/M^2 (body surface area); Cohort 4： Lymphodepletion chemotherapy + CART-PSMA cells 1-3x10^8/M^2 (body surface area).

Study groups in NCT05656573
Study groupRoleWhat they receive
autologous CART-PSMA cellsExperimentalCohort 1： CART-PSMA cells 1-3x10^7/M^2(body surface area) on Day 0; Cohort 2： CART-PSMA cells 1-3x10^8/M^2(body surface area) on Day 0; Cohort 3： Lymphodepletion chemotherapy with fludarabine (30 mg/m2 body surface area) plus cyclophosphamide (300 mg/m2 body surface area) for 3 consecutive days during D-7 to D-3, followed by the infusion of CART-PSMA cells at 1-3x10^7/M^2(body surface area) on Day 0. Cohort 4： Lymphodepletion chemotherapy with fludarabine (30 mg/m2 body surface area) plus cyclophosphamide (300 mg/m2 body surface area) for 3 consecutive days during D-7 to D-3, followed by the infusion of CART-PSMA cells at 1-3x10^8/M^2(body surface area) on Day 0.
Receives: Drug: CART-PSMA cells

What is being measured

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

  1. Occurrence of study related adverse events, laboratory toxicities and clinical events that are possibly, likely, or definitely related to study participation.

    Assessing the type, frequency, severity, and duration of adverse events as a result of CART-PSMA cell infusion via physical, laboratory and imaging examination.

    Measured: Up to 15 years

Secondary outcomes (8)

  1. The persistence, accumulation, and migration of CART-PSMA cells.

    Assessing the trafficking of CART-PSMA cells in the peripheral blood by quantifying the mRNA of CAR gene at the time of each infusion as well as at each time of follow-up blood collection. Peripheral blood will be collected prior to the initial infusion and will be set as baseline.

    Measured: Up to 2 years

  2. Overall survival (OS)

    Estimating median OS from CART-PSMA cell infusion to the event date (death) or last contact date (censor date) by Kaplan Meier methods.

    Measured: Up to 15 years

  3. Progression-free survival (PFS)

    Estimating median PFS by survival without biochemical (PSA) or radiographic evidence of disease progression or relapse from CART-PSMA cell infusion to event date (progression/relapse or death); the censor date: off protocol therapy date (required disallowed treatment or withdrawal of consent for further therapy) or last contact date.

    Measured: Up to 15 years

  4. Patterns of change in PSA (prostate-specific antigen)

    Assessing PSA response by the percentage of change in PSA from baseline to the defined time-frame on therapy (or earlier if patients discontinue therapy prior to the time-frame) as well as the maximum decline in PSA that occurs at any point during CART-PSMA cell infusion.

    Measured: Up to 5 years

  5. Serum cytokine profile

    Assessing potential cytokine release syndrome (CRS) toxicity and CART cell effector function, sequential serum samples by analysis of Th1/Th2 cytokines (e.g., IL-2, IFNgamma, TNFalpha, IL-10, GMCSF, IL-6, MIP-1alpha) before and after CART-PSMA cell infusion.

    Measured: Up to 2 years

  6. Phenotypes and frequencies of immune cell subsets in the peripheral blood pre- and post-therapy

    Assessing phenotypes and frequencies of immune cell subsets in the peripheral blood, T cell subsets and phenotypes utilising groups of labelled antibodies.

    Measured: Up to 2 years

  7. Changes in circulating tumor cells in peripheral blood

    Assessing changes in levels of circulating tumor cells (CTC) to investigate if decreases in CTC levels correlate with response.

    Measured: Up to 2 years

  8. Circulating cell-free deoxyribonucleic acid (cfDNA) in peripheral blood

    Assessing changes in levels of cfDNA to investigate if decreases in cfDNA levels correlate with response.

    Measured: Up to 2 years

Timeline

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

  1. First posted19 Dec 2022
  2. Study start1 Mar 2023
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2025 (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
Sequential
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05656573
Sponsor's protocol ID
NT1921-H301-CART-PSMA
Status last verified
Nov 2024
First submitted
1 Dec 2022
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CART-PSMA cells in people with Prostate Cancer, run by Nova Therapeutics LLC 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 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 15 Nov 2024. 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?

Contact Jay Zhang, MD/PhD (858-205-4558, jiezhang8@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of study related adverse events, laboratory toxicities and clinical events that are possibly, likely, or definitely related to study participation. (time frame: Up to 15 years). 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 NCT05656573.

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 15 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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