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

NCT06240767 | Unknown Phase 1

• 1 other identifier: WX03-02B0205-072100-62
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor, Adult; Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy evaluation

  Target lesions were assessed according to RECIST1.1 criteria. All other lesions, including small lesions (lesions with a maximum diameter of less than 20mm measured by conventional methods or less than 10mm measured by spiral CT scanning, or less than 15mm measured when the CT layer thickness is 5mm) and true unmeasurable lesions are not required to be measured, described as "with" or "without".

  6 months after treatment

Study Arms (1)

Clinical study of human granulocyte in the treatment of advanced recurrent tumor

EXPERIMENTAL

Experimental: Anticancer mouse characteristic human granulocyte treatment of advanced recurrent tumors. 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.

Biological: Granulocyte infusion

Interventions

Granulocyte infusion BIOLOGICAL

The number of single granulocytes per infusion was 2.0-5.0×10\^10, with an interval of 2±1 day and 5 continuous infusions.

Clinical study of human granulocyte in the treatment of advanced recurrent tumor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 \~ 75 years old (inclusive), gender is not limited
• Malignant tumor confirmed by puncture pathology/postoperative pathology, or PET-CT multi-focal high signal, clinical stage IV
• Physical status score of 0-2 in ECOG scale
• Expected survival time ≥3 months
• 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
• 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)
• 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)
• Anti-neutrophil antibody test results are negative
• The patient volunteered and signed the informed consent

You may not qualify if:

• : Uncontrolled or severe cardiovascular disease, diabetes, major heart disease, such as arrhythmia within 30 days, congestive heart failure, or severe coronary artery disease
• : HIV infection, no recent (within 30 days) use of immunosuppressive drugs other than steroids
• : Pregnant and lactating women
• : Previous history of stem cell and organ transplantation
• : Patients who have been using or are using immunosuppressants for a long time
• : Symptomatic brain metastases are not controlled
• : People who are known to be severely allergic to granulocyte infusion (or test positive for anti-neutrophil antibodies)
• : People with coagulation disorders
• : Mental disorders are not under control
• : Patients with severe autoimmune diseases

Sponsors & Collaborators

• Wuxi People's Hospital: lead

Study Sites (1)

Wuxi People's Hospital

Wuxi, Jiangsu, 214043, China

RECRUITING

Central Study Contacts

Peihua Lu, Doctor

CONTACT

13621500031; 13625653@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: February 5, 2024
• Study Start: November 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 5, 2024

Record last verified: 2023-09

Locations

CN (1)