NCT05732948

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2018-08-02
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-02-17
• Last updated: 2023-11-29

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study