Actively Recruiting
PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors
Led by Shenzhen Celconta Life Science Co., Ltd. · Updated on 2025-03-26
18
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A single-center, single-arm, dose-escalation exploratory clinical trial on the safety and efficacy of PANK-003 cell injection(Peripheral blood-derived allogeneic natural killer cells )combined with standard adjuvant chemotherapy after surgery in patients with solid tumors
CONDITIONS
Official Title
PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign the informed consent form
- Age between 18 and 75 years old at screening, any gender
- Histologically confirmed or imaging diagnosed malignant solid tumors (lung, esophageal, gastric, breast) after surgery
- Have undergone surgery and are to receive or are receiving postoperative adjuvant chemotherapy
- Expected survival time of more than 6 months at enrollment
- ECOG performance status score of 0 or 1
- Meet laboratory requirements at screening: white blood cell count 6 3.0�d710�b9/L; neutrophil count 6 1.5�d710�b9/L; lymphocyte count 6 0.5�d710�b9/L; hemoglobin 6 90 g/L; platelets 6 75�d710�b9/L; serum total bilirubin 4 2.0�d7 upper limit of normal (ULN), or 4 3�d7ULN if history of Gilbert's syndrome; AST and ALT 4 2.5�d7ULN; creatinine < 1.5�d7ULN with creatinine clearance rate 6 50 mL/min
- Good lung function with baseline fingertip pulse oximetry saturation 6 95% in room air
- Female subjects of childbearing age must have a negative serum pregnancy test at screening and use effective contraception during the study and 1 year after
- Male subjects with partners of childbearing age must be surgically sterilized or agree to use effective contraception during the study and 1 year after
- Evaluated by investigator as suitable for the study
You will not qualify if you...
- Pregnant or breastfeeding women
- History of allergy to any component of the cell product
- Other malignant tumors except cured non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer, superficial bladder cancer, or tumors with disease-free survival > 5 years
- Positive for hepatitis B surface antigen or e antigen, or hepatitis B antibodies with measurable HBV-DNA above limit
- Positive for hepatitis C antibody, Treponema pallidum antibody, or HIV antibody
- Received drugs from other clinical trials or cellular immunotherapies within 28 days before screening
- Received live or attenuated vaccines within 4 weeks before NK cell infusion
- Comorbidities requiring systemic corticosteroids or immunosuppressive drugs during study
- High allergic constitution or allergies to NK product components or common emergency/anesthetic drugs
- Unstable circulatory system diseases within 180 days before screening, including unstable angina, myocardial infarction, severe heart failure (NYHA class 6 III), severe arrhythmia needing drugs, or recent angioplasty/stent/bypass
- Other diseases or conditions deemed unsuitable by investigator, including poorly controlled diabetes, infections, CNS diseases, bleeding or clotting disorders, poor compliance, or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AnYang Tumor Hospital
Anyang, Henan, China, 455000
Actively Recruiting
Research Team
B
Baozhong Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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