Solid Tumor, AdultPhase 1NCT06240767
Clinical Study on the Treatment of Advanced Recurrent Tumors With Anticancer Mouse Characteristic Human Neutrophils
A Phase 1 study testing Granulocyte infusion in people with Solid Tumor, Adult and Advanced Cancer, run by Wuxi People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Adult, Advanced Cancer
- What is being tested?
- Granulocyte infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214043
Peihua Lu, MD, +86 13621500031, 13625653@qq.com
About this study
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.
Read the detailed 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.
- Conditions
- Solid Tumor, Adult, Advanced Cancer
- Being tested
- Granulocyte infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte infusionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Granulocyte infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Nov 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240767
- Sponsor's protocol ID
- WX03-02B0205-072100-62
- Status last verified
- Sep 2023
- First submitted
- 12 Jun 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Advanced Recurrent Tumors With Anticancer Mouse Characteristic Human Neutrophils
- ClinicalTrials.gov ID
- NCT06240767
- Acronym / sponsor ID
- WX03-02B0205-072100-62
- Conditions
- Solid Tumor, Adult, Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Wuxi People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical study of human granulocyte in the treatment of advanced recurrent tumor | Experimental | Biological: Granulocyte infusionExperimental: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granulocyte infusionThe number of single granulocytes per infusion was 2.0-5.0×10^10, with an interval of 2±1 day and 5 continuous infusions. | Biological | Clinical study of human granulocyte in the treatment of advanced recurrent tumor |
Primary outcome
Clinical efficacy evaluation
Time frame: 6 months after treatment
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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Granulocyte infusion in people with Solid Tumor, Adult and Advanced Cancer, run by Wuxi People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peihua Lu, Doctor (13621500031, 13625653@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy evaluation (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.