Exciting News Alert! China’s New TCR-T Product IND Approved for Synovial Sarcoma!
🌟 Exciting News Alert! China’s New TCR-T Product IND Approved for Synovial Sarcoma! 🌟
synovial sarcoma
“Engineered T Cell Receptor-T Cell Therapy,” or “TCR-T (engineered T cell receptor-T cell, TCR-T) cell therapy,” involves the extraction of peripheral blood mononuclear cell (PBMC) samples from patients, followed by genetic engineering to introduce selected high-affinity T cell receptors (TCRs) into T cells. This enables them to seek out and specifically recognize tumor antigens, effectively targeting and killing cancer cells.
In early 2022, the Food and Drug Administration (FDA) in the United States approved a TCR-T therapy called “Kimmtrack” for treating uveal melanoma, marking a significant milestone in solid tumor treatment.
Recently, the prestigious international journal “Cell Rep Med” reported the Phase I clinical trial results of China’s first investigational new drug (IND) approved by the FDA for TCR-T cell therapy — TAEST16001. This groundbreaking research represents a crucial step forward in the clinical translation of adoptive T cell immunotherapy for advanced soft tissue sarcoma and holds the potential to become the world’s second marketed TCR-T cell therapy targeting solid tumors!
Cell Rep Med
China’s first TCR-T product IND approval takes aim at synovial sarcoma.
TAEST16001,
developed independently by Xiangxue Life Sciences, is a TCR-T cell product. The Phase I clinical trial enrolled 12 patients with advanced soft tissue sarcomas who were HLA-A*02:01 positive and expressed the NY-ESO-1 antigen. Among them, 10 patients had synovial sarcoma, while 2 had liposarcoma (1 myxoid liposarcoma and 1 dedifferentiated liposarcoma), with a median age of 33 (25-67) years. 58.3% (7/12) of patients were male. Before enrollment, 83.3% of patients had received at least two types of chemotherapy. After enrollment, all patients underwent modified lymphocyte clearance surgery followed by infusion treatment with TAEST16001 cells.
After a median treatment duration of 43 days, 9 out of 12 patients (75%) showed tumor regression (Figure 1), with a median time to response (TTR) of 1.9 months and a median duration of response of 13.1 months. Six patients (50%) exhibited sustained tumor burden reduction after the first radiological assessment. In the primary analysis, 5 out of 12 patients achieved partial responses, resulting in an objective response rate (ORR) of 41.7% (95% CI, 15.2–72.3). Disease stabilization was observed in 5 cases [41.7% (95% CI, 15.2–72.3)], yielding a disease control rate of 83.3% (95% CI, 51.6–97.9). The median progression-free survival (PFS) was 7.2 months (95% CI, 2.5–11.8).
TCR-T Therapy
How to Seek TCR-T Therapy Assistance
Several TCR-T therapies under development in China are urgently recruiting patients with hepatitis B virus-related liver hepatocellular carcinoma, head and neck tumors (oral cancer, laryngeal cancer, etc.), advanced cervical cancer, and anal cancer.
If you wish to assess whether your condition is suitable for CAR-T therapy, you can submit your pathological reports, treatment history, and discharge summaries to
<Advanced Medicine in China> doctor.huang@globecancer.com for preliminary evaluation.
or click on the WhatsApp+8613717959070
Stay tuned for more updates on this groundbreaking advancement in cancer treatment! 🌟
#CancerResearch #TCRTtherapy #SynovialSarcoma #MedicalInnovation