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

NCT05732948 | Unknown Phase 1 FDA Drug

• 1 other identifier: UCTPSMA-PSCA v1.0
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor response is assessmented with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  Dose escalation is based on the dose limiting toxicity (DLT). In this phase I trial, dose escalation will be based on the DLT, defined as a grade 3 or 4 toxicity (excluding alopecia, fatigue) developing after infusion of the T cells as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Scale (CTCAE) Version 3.0. Only toxicities that are possibly, probably, or definitely related to treatment will be considered DLTs. Patients will be observed for DLTs four weeks (28 days) from the T cell infusion

  8 weeks

Secondary Outcomes (1)

• Asverse event is evaluated with CTCAE, version 4.0

  8 weeks

Study Arms (1)

autologous T cells & cyclophosphamide

EXPERIMENTAL

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.

Drug: autologous T cells & cyclophosphamide

Interventions

autologous T cells & cyclophosphamide 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.

autologous T cells & cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Patients with congenital immunodeficiency;
• There is a history of myocardial infarction and serious arrhythmia within six months;

Sponsors & Collaborators

• Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd: lead
• The First Affiliated Hospital of Soochow University: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Tang Xiaowen

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Tang Xiaowen, Ph.D

CONTACT

（0086）51267781856; tangxiaowen@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: February 17, 2023
• Study Start: August 2, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)