NCT06619886

TP53 R248Q TCR-T Cell Therapy for Advanced Solid Tumor

Early Clinical Study to Evaluate the Safety and Efficacy of TP53 R248Q Mutation-specific TCR-T Cell Therapy for Advanced Solid Tumor

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of T cell therapy with mutated TP53 R248Q specific TCR transduction in patients with advanced solid tumor expressing the TP53 R248Q mutation and the HLA-A\*11:01 allele.

Detailed description

Malignant tumors are a major disease threatening the health of the Chinese people, with about 4.6 million new cancer patients and 2 million deaths each year in China. P53 gene mutation is an important driver gene in the pathogenesis of malignant tumors. P53 gene mutation is present in about half of cancer patients. Tumors carrying P53 gene mutation are insensitive to treatment, have poor response, are easy to be resistant, are easy to relapse, and have a high mortality rate. At present, there is no drug that directly targets P53 gene mutation. Our laboratory has previously built a TCR-T cell R \& D platform. Using this platform, we have successfully developed a TCR-T cell specific killing function for tumor cells targeting the R248Q mutation of the most common TP53 protein in hematological tumors and targeting the most high-frequency HLA-A11:01 subtype of TCR-T cells in the Chinese population using in vitro and in vivo animal models, and applied for a Chinese invention patent and PCT invention patent. The findings provide new ideas and treatment methods for immune cell therapy of malignant tumors. At present, we cooperate with the hematology clinical team of Shanghai First People's Hospital and Shanghai Pharmaceutical Group Biotherapy Technology Co., Ltd. to prepare to carry out investigator-initiated clinical trials.

Conditions

• Solid Tumor, Adult
• Lung Adenocarcinoma
• Pancreas Cancer
• Colorectal Cancer
• Other Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Autologous, engineered T Cells targeting TP53 R248Q	TP53-R248Q mutant TCR-T Cells Injection, 28 days as a treatment cycle (cycle number N≤3), each cycle was divided into three D0, D7, D14 infusion, a total of 3 dose groups were set up, the single infusion of cells within the range of ±20% all meet the requirements

Timeline

• Start date: 2024-09-24
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: China