KangAi RuiHao Launches Phase I Clinical Trial of Autologous Lymphocyte Injection (KACM001) for Adjuvant Therapy in Hepatocellular Carcinoma Patients at High Risk of Recurrence Post-Resection

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that the Phase I clinical trial for tolerance, safety, and preliminary efficacy of Beijing Biohealthcare Biotechnology Co., Ltd.'s autologous lymphocyte injection (KACM001 injection) for adjuvant treatment in patients with high recurrence risk after radical resection of hepatocellular carcinoma has been initiated. The clinical trial registration number is CTR20253617, and the initial information disclosure date was September 5, 2025.

The drug formulation is an injectable, with a specification of 60mL/bag. Phase I consists of two dosage groups: the low-dosage group receives one bag of cells per infusion, while the high-dosage group receives three bags per infusion. Each subject will undergo 9 to 16 cell infusions. The purpose of this trial is to study the tolerability, safety, and preliminary efficacy of autologous lymphocyte injection as adjuvant therapy for individuals at high risk of recurrence after curative surgery for hepatocellular carcinoma.

Autologous Lymphocyte Injection is a biologic product indicated for hepatocellular carcinoma. Hepatocellular carcinoma is a common malignant liver tumor with symptoms including pain in the liver area, abdominal distension, fatigue, etc. Diagnosis mainly relies on imaging examinations and serum tumor marker tests, such as alpha-fetoprotein.

The primary endpoint indicators of this trial include the incidence of DLT, AE, and SAE in Phase Ⅰ, blood routine and other examination indicators, vital signs, etc., as well as RFS in Phase Ⅱ; secondary endpoint indicators include relapse-free survival (RFS), OS, RFS%, and in Phase Ⅱ also include the incidence of AE and SAE, etc.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 69 participants.

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Editor: Xiaolang Express