NCT05732948

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

Status unknown Phase 1 Last updated 29 November 2023

What this trial tests

Phase 1 trial testing autologous T cells & cyclophosphamide in Prostate Cancer in 12 participants. Status unknown.

Timeline

2 August 2018

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	2 August 2018
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	1 location across China

Drugs / interventions tested

• autologous T cells & cyclophosphamide — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd — full company profile →

Who can join

Adults 18 to 70, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prospects and challenges of CAR-T cell therapy combined with ICIs.
   Lv Y, Luo X, Xie Z, Qiu J, et al · · 2024 · cited 38× · PMID 38571495 · DOI 10.3389/fonc.2024.1368732
2. Emerging Immunotherapy Approaches for Treating Prostate Cancer.
   Meng L, Yang Y, Mortazavi A, Zhang J. · · 2023 · cited 25× · PMID 37762648 · DOI 10.3390/ijms241814347
3. Expanding the Horizons of CAR-T Cell Therapy: A Review of Therapeutic Targets Across Diverse Diseases.
   Hernández-López A, Olaya-Vargas A, Bustamante-Ogando JC, Meneses-Acosta A. · · 2025 · cited 10× · PMID 40005970 · DOI 10.3390/ph18020156
4. Breaking barriers: enhancing CAR-armored T cell therapy for solid tumors through microenvironment remodeling.
   Andreou T, Neophytou C, Kalli M, Mpekris F, et al · · 2025 · cited 7× · PMID 40969762 · DOI 10.3389/fimmu.2025.1638186
5. Arming Vδ2 T Cells with Chimeric Antigen Receptors to Combat Cancer.
   Thomas P, Paris P, Pecqueur C. · · 2024 · cited 7× · PMID 38747974 · DOI 10.1158/1078-0432.ccr-23-3495
6. The application of emerging immunotherapy in the treatment of prostate cancer: progress, dilemma and promise.
   Che J, Liu Y, Liu Y, Song J, et al · · 2025 · cited 6× · PMID 40145100 · DOI 10.3389/fimmu.2025.1544882
7. Novel strategies to overcome tumor immunotherapy resistance using CAR NK cells.
   Guo JH, Afzal A, Ahmad S, Saeed G, et al · · 2025 · cited 5× · PMID 40510336 · DOI 10.3389/fimmu.2025.1550652
8. Emerging roles for stromal cells in bone metastasis.
   Nyman KJ, Frieling JS, Lynch CC. · · 2024 · cited 2× · PMID 38984147 · DOI 10.1016/j.jbo.2024.100610