Treatment for advanced recurrent tumors using specialized human neutrophils
Clinical Study on the Treatment of Advanced Recurrent Tumors With Anticancer Mouse Characteristic Human Neutrophils
This study is testing whether infusions of special immune cells can help people with advanced solid tumors that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Wuxi People's Hospital Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Wuxi, Jiangsu) |
| Trial ID | NCT06240767 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to recruit approximately 100 patients with advanced solid tumors that have not responded to standard treatments. Participants will receive a series of five infusions of human granulocytes with anti-cancer properties, administered every 2±1 days. The study will monitor the safety and efficacy of this treatment approach, with the possibility of additional cycles based on patient response and investigator discretion. The focus is on patients with various types of advanced cancers, including non-small cell lung cancer and breast cancer, among others.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced solid tumors that have progressed after standard treatments.
Not a fit: Patients with early-stage cancers or those who have not yet undergone standard treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that have failed conventional therapies.
How similar studies have performed: While this approach is novel, similar studies using immune cell therapies have shown promising results in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 \~ 75 years old (inclusive), gender is not limited 2. Malignant tumor confirmed by puncture pathology/postoperative pathology, or PET-CT multi-focal high signal, clinical stage IV 3. Physical status score of 0-2 in ECOG scale 4. Expected survival time ≥3 months 5. Have measurable lesions, calculate the sum of the longest diameter of all target lesions, and report as the baseline sum diameter: the lesions can be accurately measured in at least one direction (record the longest diameter), as long as it conforms to RECIST1.1; If there are multiple lesions, a maximum of 5 lesions (no more than 2 per organ) are required; The efficacy of hematological malignancies such as leukemia can be confirmed by cytology/histology 6. more than 4 weeks have elapsed since previous drug therapy, radiation therapy and surgery; Oral fluorouracil and small molecule targeted drugs required for more than 2 weeks or within 5 half-lives of the drug (whichever is longer) 7. Laboratory tests meet the following criteria: (1) Bone marrow function: absolute count of blood neutrophils (ANC) ≥1\*10\^9/L, platelets (PLT) ≥75\*10\^9/L; (2) Liver function: serum total bilirubin (STB), bound bilirubin (CB) ≤ upper limit of normal (ULN) \*1.5, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN\*2.5 (in the absence of liver metastasis), or ≤ULN\*5 (in the presence of liver metastasis); (3) Kidney function: serum creatinine (Cr) ≤ULN\*1.5, endogenous creatinine clearance (Ccr) ≥50 mL/min (calculated by Cockcroft-Gault formula) 8. Anti-neutrophil antibody test results are negative 9. The patient volunteered and signed the informed consent Exclusion Criteria: * 1: Uncontrolled or severe cardiovascular disease, diabetes, major heart disease, such as arrhythmia within 30 days, congestive heart failure, or severe coronary artery disease 2: HIV infection, no recent (within 30 days) use of immunosuppressive drugs other than steroids 3: Pregnant and lactating women 4: Previous history of stem cell and organ transplantation 5: Patients who have been using or are using immunosuppressants for a long time 6: Symptomatic brain metastases are not controlled 7: People who are known to be severely allergic to granulocyte infusion (or test positive for anti-neutrophil antibodies) 8: People with coagulation disorders 9: Mental disorders are not under control 10: Patients with severe autoimmune diseases 11: Cases deemed unsuitable for inclusion by the investigator
Where this trial is running
Wuxi, Jiangsu
- Wuxi People's Hospital — Wuxi, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Peihua Lu, Doctor
- Email: 13625653@qq.com
- Phone: 13621500031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.