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PD-1 Silent PSMA/PSCA Targeted CAR-T for the Treatment of Prostate Cancer

NCT ID: NCT05732948

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-02

Study Completion Date

2024-12-31

Brief Summary

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This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune cells (T cells) used in this study will be the patients own immune cells. They will be removed from the patients blood, changed in the laboratory, and then put back into their body. T cells help the body fight infections. These cells may also kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer cells. For this reason, the physician will change the T cells by putting in a gene so that they may be able to better recognize and kill the prostate cancer cells. A gene is a portion of information which comes from the DNA and tells the cell what to do. This gene will be put into the patients T cells by a weakened virus. It is hoped that this approach will help the T cells recognize the prostate cancer tumor cells and possibly kill them. This is an entirely new treatment for prostate cancer and it is not known if it will have any beneficial or unexpected harmful effects.

Detailed Description

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Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. It has become the fourth tumor treatment model after traditional tumor therapies (surgery, chemotherapy, radiotherapy) . With the development of the research field, the CAR-T cell basis and clinical research of various targets have achieved good results. PSCA, PSMA,RORγ are potential targets and spectacular paradigm in the diagnosis and treatment of prostate cancer. This study is for evaluation of the safety and efficacy of PD-1(programmed death 1)silent PSMA(prostate-specific membrane antigen)/PSCA(prostate stem cell antigen)targeted CAR-T for the Treatment of Castrate Metastatic Prostate Cancer

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous T cells & cyclophosphamide

This is a phase I dose escalation study to assess the safety and tolerability using increasing doses of engineered autologous T cells PD-1 silent targeted to PSMA/PSMA administered one day after pretreatment with cyclophosphamide.

Group Type EXPERIMENTAL

autologous T cells & cyclophosphamide

Intervention Type DRUG

This is a phase I dose escalation study to assess the safety and tolerability using increasing doses of PD-1(programmed death 1)silent PSMA(prostate-specific membrane antigen)/PSCA(prostate stem cell antigen)targeted CAR-T administered one day after pretreatment with cyclophosphamide.

Interventions

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autologous T cells & cyclophosphamide

This is a phase I dose escalation study to assess the safety and tolerability using increasing doses of PD-1(programmed death 1)silent PSMA(prostate-specific membrane antigen)/PSCA(prostate stem cell antigen)targeted CAR-T administered one day after pretreatment with cyclophosphamide.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Evidence of metastatic disease in bone on bone scan, CT scan, and/or by MRI atany time following the initial diagnosis of prostate cancer;
* The corresponding antigens such as PSMA and PSCA/PDL1 were highly expressed;
* Male patients aged between 18 and 65;
* Karnofsky score ≥ 60, ECOG≤ 2;
* Important organ function as defined by the following: cardiac ejection fraction ≥ 50%; electrocardiogram showed no obvious abnormalities; creatinine clearance rate calculated by using Cockcroft- Gault formula ≥40ml/min ; ALT/AST≤ 3×the institution normal upper limit; total bilirubin ≤2.0mg/dl; coagulation function: PT/ APPT\<2 ×the institution normal upper limit; SpO2 \>92%; Blood: hemoglobin\>80g/L, ANC ≥ 1, PLT ≥ 50×109/L;
* There is measurable target lesion;
* Voluntary informed consent is given;

Exclusion Criteria

* Immunosuppressive drugs or hormones were used a week before admission;
* Severe active infection;
* Human immunodeficiency virus (HIV) positive;
* Active hepatitis B or C infection;
* Past medical history of other malignancies. Not included: patients who have been cured at any time prior to the treatment of the skin basal or squamous cell carcinoma and cervical carcinoma in situ; the other tumor has not listed above, but has been used and only cured by surgery, without further treatment by other measures, the subjects of disease-free survival more than 5 years, can be included in the study;
* Patients participating in other clinical trials;
* The researchers thought the subjects were unfit for inclusion or unable to participate in or complete the study;
* Patients with congenital immunodeficiency;
* There is a history of myocardial infarction and serious arrhythmia within six months;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tang Xiaowen

Role: STUDY_CHAIR

The First Affiliated Hospital of Soochow University

Locations

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The First Affiliated Hospital of Soochow University

Suzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tang Xiaowen, Ph.D

Role: CONTACT

[email protected]
（0086）51267781856

Facility Contacts

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Xiaowen Tang, Ph.D

Role: primary

[email protected]
(0086)51267781856

Other Identifiers

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UCTPSMA-PSCA v1.0

Identifier Type: -

Identifier Source: org_study_id