NCT06756295

A Phase I/ II Study of Fragmented Autoantigen Stimulated T-cell-immunotherapy Combined with Radiotherapy (FAST-CR)

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Fengming Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation and exploration of the phase I/II clinical safety and efficacy of personalized FAST(Radiation fueled antigens stimulated T-cell immunotherapy )cancer vaccine combined with radiotherapy.

Detailed description

Tumor whole-cell vaccines, as one of the methods for tumor immunotherapy, have become a key focus of numerous preclinical studies. Among these, the latest approaches include cryopreserved silica-based vaccines/aged cell vaccines and genetically engineered vaccines. These vaccines induce immunogenic cell death in tumor cells, thereby reshaping the body's immune tolerance and promoting in-situ immunity (in-situ vaccination). They enhance the diversity of tumor-associated antigens in the draining lymph nodes, increase the recruitment of T cells, and promote tumor recognition and anti-tumor effects. At the same time, whole-cell vaccines retain all potential antigens of the tumor cells, and this integrity increases the likelihood of immune activation and recognition of distal tumors. Additionally, since the vaccine uses the patient's own tumor tissue, it reduces the risk of immune overactivation that might be caused by foreign components. Preclinical studies have found that in a surgical resection model of primary tumors in experimental animals, the FAST vaccine can significantly inhibit the recurrence and metastasis of tumor lesions, remodel the immune microenvironment of colonized organs, achieve systemic clearance of micro-metastases, suppress tumor recurrence and metastatic progression, and prolong the survival of the experimental animals. On the other hand, many advanced cancer patients in the clinic are not amenable to surgical resection, with a high tumor burden. Moreover, the immune response induced by the whole-cell autologous FAST vaccine requires a certain period to develop. Therefore, in our preclinical study, the investigators combined FAST vaccine administration with radiotherapy to control local tumors in experimental animals. The results showed that this approach significantly enhanced both innate and adaptive immunity, inhibited tumor progression and metastasis, and improved the survival rate of the experimental animals. This study aims to recruit tumor patients who have undergone standard surgical treatment and those with advanced tumors who have failed standard treatment or experienced disease progression (after failure of third-line treatment),Using the patient's individualized tumor tissue, the investigators will prepare the FAST tumor cell vaccine and combine it with precision radiotherapy to conduct safety and efficacy studies on tumor patients who meet the inclusion criteria.

Conditions

• Breast Cancer, Colorectal Cancer
• Melanoma
• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	individualized tumor FAST vaccine combination (including adjuvant)	Using the patient's individual tumor tissue, an autologous FAST (Fragmented Autoantigen Stimulated T-cell Immunotherapy) vaccine is prepared.

Timeline

• Start date: 2025-03-25
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2025-01-01
• Last updated: 2025-03-12