Nanjing Kaidi Medical Announces Continued Confirmed Responses in Advanced Gastric Cancer with Dual-Target CAR-T Therapy KD-496

November 27, 2024

eMedClub News

Recently,Nanjing Kaidi Biotechnology Co., Ltd.（"Abbreviation:"Kaidi Medical）Released byDepartment of Gastrointestinal Oncology, Peking University Cancer HospitalKD-496 CAR-T Cells（IIT）Latest Advances in Clinical Trials.Two casesAll had failed in second-line anti-tumor treatment.Patients with gastric cancer received an infusion of low-dose KD-496 CAR-T cells.First PatientAt the first tumor assessment 4 weeks after treatment, the target lesions had significantly shrunk, directly reachingTo partial remission;InThe tumor continued to shrink at the second tumor evaluation conducted 8 weeks after treatment.The patient achieved sustained confirmed relief three months post-treatment.. The second case also reached a reduction of SD 4 weeks after treatment.As of now，The patient tolerated well, without obvious gastrointestinal reactions.This may be attributed to the dual-target design of the product.

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This itemSingle-center, open-label, single-arm clinicalStudy (NCT06134960) evaluated KD-496 CAR-T therapyAdvanced NKG2DL+/CLDN18.2+ Solid TumorsSafety and effectiveness.KD-496 CAR-T Therapy for Advanced Dual-Antigen NKG2DL+/CLDN18.2+ Solid Tumors Mainly Targets Gastric Cancer and Pancreatic Cancer. Gastric cancer is a common digestive system tumor, a malignant tumor originating from the gastric mucosal epithelial cells. It is one of the most common cancers in China, with more than 400,000 new cases each year. Both its incidence and mortality rank among the top five malignant tumors in China. Despite recent advancements in gastric cancer treatment, the prognosis for patients with advanced gastric cancer remains poor.

➤ DiseaseCase Analysis 1

• The first patient was diagnosed with poorly differentiated adenocarcinoma of the greater curvature of the stomach body accompanied by signet-ring cell carcinoma, along with peritoneal wall and lymph node metastases in December 2023. In January 2024, a laparoscopic exploration was performed, followed by treatment with fluorouracil, calcium folinate, oxaliplatin, and sintilimab. Due to unsatisfactory efficacy, the regimen was changed to docetaxel, tegafur-gimeracil-oteracil potassium (S-1), oxaliplatin, and sintilimab. However, comprehensive imaging evaluation in April 2024 showed disease progression with massive ascites. Director Qi Changsong from the Department of Gastrointestinal Oncology at Peking University Cancer Hospital had thorough communication with the patient and assessed that the patient was suitable for participation in the investigator-initiated trial (IIT) clinical study of KD-496 CAR-T cell therapy.

• In late June 2024, the patient underwent apheresis. On July 1, 2024, the patient developed intestinal obstruction and pancreatitis. After symptomatic treatment, there was no significant improvement. In the absence of effective treatment, the investigator decided to proceed with CAR-T cell infusion based on the consideration of the patient's clinical benefit.

▲ Image Source: CGT Drug Development, Nanjing Kaidi Biotechnology Co., Ltd.

• The medication was successfully administered on July 22, 2024; abdominal distension began to improve on July 23, with the presence of flatus and stool passage; a small amount of liquid diet was started on August 5, and the symptoms of intestinal obstruction significantly improved after the reinfusion.

• On August 20, 2024, the first tumor assessment was conducted 4 weeks after the reinfusion treatment, showing a 33.3% reduction compared to baseline, with the tumor assessment reaching PR, and all tumor markers returning to the normal range. On September 20, a second tumor assessment was performed, indicating further tumor shrinkage with a 58.3% reduction from baseline, confirming the PR evaluation. On October 22, a third tumor assessment was carried out, showing sustained tumor shrinkage, remaining at a 58.3% reduction from baseline, again confirming partial response in the tumor assessment.