Clinical Study on the Treatment of Advanced Recurrent Tumors With Anticancer Mouse Characteristic Human Neutrophils

Last updated: January 26, 2024
Sponsor: Wuxi People's Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Metastatic Cancer

Treatment

Granulocyte infusion

Clinical Study ID

NCT06240767
WX03-02B0205-072100-62
  • Ages 18-75
  • All Genders

Study Summary

It is planned to recruit about 100 pathologically confirmed subjects with advanced solid tumors (non-small cell lung cancer, breast cancer, ovarian cancer, stomach cancer, colorectal cancer, pancreatic cancer, mesothelioma, etc.) that have progressed after standard second-line or above treatment such as surgery, chemoradiotherapy, targeted therapy and PD-1 antibody therapy. A single infusion of human granulocytes with anti-cancer mouse characteristics was performed for 5 consecutive transfusions at a interval of 2±1 day, and the safety and efficacy were clinically observed. After the investigator's judgment and discussion with the sponsor, more cycles of treatment can be received after the informed consent is completed until the criteria for stopping treatment are met.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 ~ 75 years old (inclusive), gender is not limited
  2. Malignant tumor confirmed by puncture pathology/postoperative pathology, or PET-CTmulti-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 targetlesions, and report as the baseline sum diameter: the lesions can be accuratelymeasured in at least one direction (record the longest diameter), as long as itconforms to RECIST1.1; If there are multiple lesions, a maximum of 5 lesions (no morethan 2 per organ) are required; The efficacy of hematological malignancies such asleukemia can be confirmed by cytology/histology
  6. more than 4 weeks have elapsed since previous drug therapy, radiation therapy andsurgery; Oral fluorouracil and small molecule targeted drugs required for more than 2weeks or within 5 half-lives of the drug (whichever is longer)
  7. Laboratory tests meet the following criteria: (1) Bone marrow function: absolute countof blood neutrophils (ANC) ≥110^9/L, platelets (PLT) ≥7510^9/L; (2) Liver function:serum total bilirubin (STB), bound bilirubin (CB) ≤ upper limit of normal (ULN) 1.5,alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN2.5 (in theabsence of liver metastasis), or ≤ULN5 (in the presence of liver metastasis); (3)Kidney function: serum creatinine (Cr) ≤ULN1.5, 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

Exclusion Criteria:

  • 1: Uncontrolled or severe cardiovascular disease, diabetes, major heart disease, suchas arrhythmia within 30 days, congestive heart failure, or severe coronary arterydisease 2: HIV infection, no recent (within 30 days) use of immunosuppressive drugs other thansteroids 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 testpositive 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

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Granulocyte infusion
Phase: 1
Study Start date:
November 01, 2023
Estimated Completion Date:
December 31, 2025

Study Description

100 cases of advanced cancer with failed chemotherapy or ineffective standard treatment or relief measures were enrolled and clinically observed. Single infusion dose 2.0-5.0 × 1010 granulocytes were continuously infused 5 times every 2 ± 1 day. According to the patient's condition, ensure that the number of subjects with a single tumor is not less than 20.

Connect with a study center

  • Wuxi People's Hospital

    Wuxi, Jiangsu 214043
    China

    Active - Recruiting

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