Clinical trial of the world's first innovative dual-targeted CAR-T cell drug (KD-496) has been completed in a subject with pancreatic cancer
The study (NCT06134960) is an investigator-initiated clinical trial (IIT) aimed at evaluating the safety and efficacy of KD-496 CAR-T therapy for advanced NKG2DL+/CLDN18.2+ solid tumors. It is a single-center, open-label, single-arm clinical study.
On March 4th, 2024, Professor Shen Lin's team from Peking University Cancer Hospital completed the infusion of KD-496 CAR-T cells in the first subject with pancreatic cancer without any adverse reactions.
KD-496 CAR-T therapy is a treatment for late-stage solid tumors with NKG2DL+/CLDN18.2+ expression, primarily targets pancreatic cancer and gastric cancer. Currently, surgery remains the main treatment approach for pancreatic cancer, supplemented by chemotherapy, radiation therapy, targeted therapy, and other adjuvant treatments. Due to the lack of specific clinical symptoms in early-stage pancreatic cancer, it is often diagnosed at an advanced stage where approximately 80% of patients have already lost the opportunity for surgical resection. The overall 5-year survival rate is less than 6%, making it the lowest among all cancers. Even after curative surgery, the 5-year survival rate for patients is still below 25%. There is an urgent need to develop various new therapies to overcome existing treatment bottlenecks. Gastric cancer is another common digestive system tumor that originates from malignant cells in the gastric mucosa epithelium. It ranks among the most prevalent cancers in China with over 400,000 new cases reported annually and high incidence and mortality rates placing it within the top five malignancies nationwide. Despite advancements in gastric cancer treatment methods in recent years, prognosis for late-stage gastric cancer patients remains poor.
We look forward to sharing more progress with everyone in the future and will continue our efforts to benefit more oncology patients. We also welcome recommendations from colleagues or relevant individuals regarding suitable candidates who can participate in this study.
We look forward to sharing more progress with you in the future and continuing our efforts to benefit more cancer patients. At the same time, We sincerely welcome peers and stakeholders to recommend suitable patients to participate in the study.
About KAEDI
KAEDI is a new drug research and development company in the clinical stage that uses leading synthetic biology technologies to develop novel cell therapy drugs for the clinically unmet needs of patients with solid tumors. Relying on its advanced synthetic biology technology platform-KD-SmCAR™, and the dual targeting CAR development platform-KD-ScCAR™. KAEDI has successfully developed a number of first-in-class cell therapy drug development pipelines for malignant solid tumors, including next-generation autologous and allogeneic CAR-T/CAR-NK cell therapy pipelines. At present, KAEDI has been declared more than 30 CAR-related patents in CN and US, and 16 patents have been authorized, among which the core pipeline KD-025 and KD-496 patents are the first authorized in CN and US.
The pre-clinical research results of KD-025 CAR-T targeting NKG2DL for Hepatocellular carcinoma, Medulloblastoma and GBM have been successively published in the international authoritative Journal of tumor immunotherapy such as “Journal for ImmunoTherapy of Cancer” and “Cancer Immunology”. At the same time, the research results were presented at the American Oncology Clinical Annual Meeting ASCO. At present, KD-025 CAR-T IIT clinical trials are being carried out in well-known clinical centers in China, and many cases have been completed, with no obvious toxic and adverse reactions, and the product is safe and effective. The first domestic CAR-T (KD-025 cell injection) targeting NKG2DL for the treatment of solid tumors IND declaration was approved. At present, KAEDI is negotiating with a number of partners to start KD-025 registration phase I clinical trial. In addition, the company's core product which is the world's first new dual-targeted CAR-T (KD-496) cell injection, has successfully entered the clinical stage of IIT.
At the same time, the company is advancing the development of the next generation of general-purpose CAR cell drugs, which is expected to develop KAEDI into a global leader in cell drugs in the near future.
KAEDI is headquartered in Nanjing, China. For more information, please visit Nanjing KAEDI Biotherapeutics Co., Ltd. official website:
English website: http://www.kaedibio.com
Chinese website: http://www.kaedibio.com/china/
Collaboration Email: business@kaedibio.com
Clinical Email: clinical.trial@kaedibio.com
On March 4th, 2024, Professor Shen Lin's team from Peking University Cancer Hospital completed the infusion of KD-496 CAR-T cells in the first subject with pancreatic cancer without any adverse reactions.
KD-496 CAR-T therapy is a treatment for late-stage solid tumors with NKG2DL+/CLDN18.2+ expression, primarily targets pancreatic cancer and gastric cancer. Currently, surgery remains the main treatment approach for pancreatic cancer, supplemented by chemotherapy, radiation therapy, targeted therapy, and other adjuvant treatments. Due to the lack of specific clinical symptoms in early-stage pancreatic cancer, it is often diagnosed at an advanced stage where approximately 80% of patients have already lost the opportunity for surgical resection. The overall 5-year survival rate is less than 6%, making it the lowest among all cancers. Even after curative surgery, the 5-year survival rate for patients is still below 25%. There is an urgent need to develop various new therapies to overcome existing treatment bottlenecks. Gastric cancer is another common digestive system tumor that originates from malignant cells in the gastric mucosa epithelium. It ranks among the most prevalent cancers in China with over 400,000 new cases reported annually and high incidence and mortality rates placing it within the top five malignancies nationwide. Despite advancements in gastric cancer treatment methods in recent years, prognosis for late-stage gastric cancer patients remains poor.
We look forward to sharing more progress with everyone in the future and will continue our efforts to benefit more oncology patients. We also welcome recommendations from colleagues or relevant individuals regarding suitable candidates who can participate in this study.
We look forward to sharing more progress with you in the future and continuing our efforts to benefit more cancer patients. At the same time, We sincerely welcome peers and stakeholders to recommend suitable patients to participate in the study.
About KAEDI
KAEDI is a new drug research and development company in the clinical stage that uses leading synthetic biology technologies to develop novel cell therapy drugs for the clinically unmet needs of patients with solid tumors. Relying on its advanced synthetic biology technology platform-KD-SmCAR™, and the dual targeting CAR development platform-KD-ScCAR™. KAEDI has successfully developed a number of first-in-class cell therapy drug development pipelines for malignant solid tumors, including next-generation autologous and allogeneic CAR-T/CAR-NK cell therapy pipelines. At present, KAEDI has been declared more than 30 CAR-related patents in CN and US, and 16 patents have been authorized, among which the core pipeline KD-025 and KD-496 patents are the first authorized in CN and US.
The pre-clinical research results of KD-025 CAR-T targeting NKG2DL for Hepatocellular carcinoma, Medulloblastoma and GBM have been successively published in the international authoritative Journal of tumor immunotherapy such as “Journal for ImmunoTherapy of Cancer” and “Cancer Immunology”. At the same time, the research results were presented at the American Oncology Clinical Annual Meeting ASCO. At present, KD-025 CAR-T IIT clinical trials are being carried out in well-known clinical centers in China, and many cases have been completed, with no obvious toxic and adverse reactions, and the product is safe and effective. The first domestic CAR-T (KD-025 cell injection) targeting NKG2DL for the treatment of solid tumors IND declaration was approved. At present, KAEDI is negotiating with a number of partners to start KD-025 registration phase I clinical trial. In addition, the company's core product which is the world's first new dual-targeted CAR-T (KD-496) cell injection, has successfully entered the clinical stage of IIT.
At the same time, the company is advancing the development of the next generation of general-purpose CAR cell drugs, which is expected to develop KAEDI into a global leader in cell drugs in the near future.
KAEDI is headquartered in Nanjing, China. For more information, please visit Nanjing KAEDI Biotherapeutics Co., Ltd. official website:
English website: http://www.kaedibio.com
Chinese website: http://www.kaedibio.com/china/
Collaboration Email: business@kaedibio.com
Clinical Email: clinical.trial@kaedibio.com