Clinical trial · Interventional
Clinical Study of MAK Immune Cells in the Treatment of PHC
Clinical Study on the Safety and Efficacy of Mixed-activated Killer Immune Cells in the Treatment of Primary Hepatocellular Carcinoma
NCT05242757CI-TRIAL-00056566unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators will plan to recruit 20 patients with liver cancer CNLC stage Ⅲa and Ⅲb who are older than 18 years old. Peripheral blood mononuclear cells were obtained and then the MAK(Mixed-activated Killer) cells were injected, and then the safety and efficacy were observed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mixed-activated Killer Immune Cells | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- To evaluate the safety and reliminary efficacy of MAK immune cells in the treatment of PHC.
- description
- To evaluate the safety and reliminary efficacy of MAK immune cells in the treatment of primary hepatocellular carcinoma.
- interventionNames
- Other: Mixed-activated Killer Immune Cells
Primary outcomes (2)
- measure
- Detecting the dynamic changes of circulating tumor cell count ( > 4 CTC counts per milliliter of blood acted as positive )
- timeFrame
- three months
- description
- Peripheral blood was collected 6 times at baseline, 24 hours after two MAK cell transfusions, and 1, 2, and 3 months after the last MAK cell transfusions to detect the changes in the number of circulating tumor cells ( \> 4 CTC counts per milliliter of blood acted as positive ).
- measure
- The size (tumor diameter) and number (tumor recurrence lesions) of PHC tumors were examined by enhanced abdominal CT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age over 18 years old, regardless of gender. 2. Patients with primary hepatocellular carcinoma. 3. According to the "Regulations for Diagnosis and Treatment of Primary Liver Cancer (2019 Edition)" by the Health Commission of the People's Republic of China Liver cancer staging scheme, patients with Ⅲa and Ⅲb. 4. The expected survival time is ≥6 months. 5. Peripheral blood white blood cell count ≥3×10\^9 /L. 6. Understand and voluntarily sign the informed consent form. Exclusion Criteria: 1. Patients with immunodeficiency or autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, multiple Primary sclerosis, insulin dependent diabetes, etc.). 2. Patients with a history of other malignant tumors in the past 5 years. 3. Patients who participated in other clinical trials or clinical research treatments within 3 months before this clinical study By. 4. Patients who have received other cell therapy within the past 6 months. 5. Patients with fever who have not effectively controlled the infection. 6. Patients with high allergies or a history of severe allergies. 7. Patients who are allergic to albumin. 8. Patients after organ transplantation; patients who have been using or are using immunosuppressive agents for a long time.
References
Publications (1)
- BACKGROUNDMorotti M, Albukhari A, Alsaadi A, Artibani M, Brenton JD, Curbishley SM, Dong T, Dustin ML, Hu Z, McGranahan N, Miller ML, Santana-Gonzalez L, Seymour LW, Shi T, Van Loo P, Yau C, White H, Wietek N, Church DN, Wedge DC, Ahmed AA. Promises and challenges of adoptive T-cell therapies for solid tumours. Br J Cancer. 2021 May;124(11):1759-1776. doi: 10.1038/s41416-021-01353-6. Epub 2021 Mar 29. PMID 33782566