Gravel Biotech's TIL Therapy GT101 Advances into Pivotal Phase II Trial for Recurrent or Metastatic Cervical Cancer
Grit Biotherapeutics
Developer of Immunotherapy Drugs for Solid Tumors
August 2024, byGravel BiotechApplication for "Multicenter, Randomized Controlled, Open-Label Phase II Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT101 Injection) for the Treatment of Recurrent or Metastatic Cervical Cancer —— National Investigators' Meeting"Successfully convened in Changsha, Hunan."
At this national investigators' meeting, Professor Wu Xiaohua from Fudan University Shanghai Cancer Center, Professor Wang Jing from Hunan Cancer Hospital, investigators from participating centers across China, the sponsor Grail Biotech team, and the ClinChoice team, along with other relevant leaders attended the meeting to jointly witness the occasion.First National Investigators' Meeting for China's First Pivotal Phase II Clinical Trial of TIL Drugs. At the meeting, all parties engaged in an in-depth discussion on the clinical research protocol for GT101 injection and had thorough communication and exchange regarding the implementation process and corresponding details of the research protocol.
GT101 Injection, a TIL product independently developed and produced by Grail Bio, is the first TIL product to enter clinical trials in China.Based on the objective response rate (ORR) of 45.5% achieved by GT101 in Phase I trials among cervical cancer patients, GT101 has officially launched a pivotal Phase II clinical study in China.TIL therapy involves isolating lymphocytes infiltrating from tumors, expanding them in vitro, and then transfusing them back into the patient, as they contain a large number of patient antigen-specific lymphocytes.TIL Cells, which can specifically recognize and kill cancer cells in patients. The world's first TIL therapy was approved for marketing in the United States on February 16, 2024, with an indication for advanced melanoma. The approval of this TIL therapy was primarily based on efficacy data showing an ORR of 31.4%.
The National Investigator Meeting was successfully held, where the attending experts discussed the positive clinical progress achieved in this trial and scientifically analyzed the key points of the study. Currently, this pivotal Phase II clinical trial is recruiting participants across multiple research centers in China. Grail Bio will work together with all research centers to strive for the early approval and market launch of the TIL drug in China, bringing world-leading treatment options to cervical cancer patients.
Introduction to the Clinical Trial of Gravel Bio's GT101 Injection
1. Brief Introduction to the Treatment Background
TIL (Tumor Infiltrating Lymphocytes) cell therapy refers to the process of isolating tumor-infiltrating lymphocytes from tumor tissue, followed by in vitro culture and large-scale expansion before being reinfused into the patient’s body. TIL therapyEffector CellsIt is a population with a high proportion and rich diversity of tumor-specific T cells, enriched through in vivo natural selection.
2. Clinical Recruitment
A clinical study on the autologous tumor-infiltrating lymphocyte injection (TIL) for patients with metastatic/recurrent advanced cervical cancer, sponsored by Grail Biotechnology Co., Ltd. The study has received ethical approval from multiple research centers.
3. If you meet the following inclusion criteria, you may be eligible to participate in this clinical study.
1. Aged ≥18 years and ≤70 years.
2. Malignant tumors confirmed by histological or cytological examination of tumor tissue obtained through opportunities such as local resection/palliative surgery.
3. Failed to respond to standard treatment, with progression occurring during or after the most recent treatment.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
5. Laboratory test values meet the protocol requirements.
Note: This clinical trial complies with the "Good Clinical Practice" and the "Helsinki Declaration".
Other pipelines of Grail Bio, such as GT201, are also recruiting patients with metastatic/recurrent advanced solid tumors of other cancer types.
If you or your family members or friends may meet the above conditions and want to learn more about the TIL cell therapy research, we will explain it to you in detail. The final decision on whether you can be included in this study will be made by the study doctor based on the study requirements.
Contact: Teacher Zhang
Contact Number: 021-58816212
