Actively Recruiting
a Single-arm, Single-center, Open Clinical Study
Led by Beijing Geekgene Technology Co., LTD · Updated on 2024-05-28
10
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial plans to enroll many patients with advanced solid tumors to complete GK01 cell transfusion, including but not limited to advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, and non-small cell lung cancer. For patients with advanced solid tumors eligible for inclusion, autologous tumor-reactive T cells (experimental drug GK01) were cultured and prepared, and a certain dose of GK01 cells was given according to the cell transfusion plan, and the safety and tolerability of the patients after transfusion were observed. Exploratory evaluation of pharmacokinetic/pharmacodynamic profiles following reinfusion and initial evaluation of efficacy of investigational drug GK01 cells according to RECIST 1.1 criteria.
CONDITIONS
Official Title
a Single-arm, Single-center, Open Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Diagnosed with incurable advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, non-small cell lung cancer, or other malignancies after failure of standard treatments
- Availability of tumor tissue or cancerous fluid suitable for isolating tumor-reactive T cells
- At least one measurable tumor lesion after tissue sampling
- ECOG performance status of 0 or 1
- Expected survival longer than 3 months
- Adequate blood counts and organ function within 14 days before tumor tissue collection
- Negative pregnancy test for women of childbearing age and agreement to use effective contraception for 1 year after infusion
- No contraindications to surgery or biopsy
- Discontinue other cancer treatments at least 7 days before tumor tissue sampling
- Signed informed consent and agreement to follow study visits and procedures
You will not qualify if you...
- Allergy to cyclophosphamide, fludarabine, interleukin-2, or any study drug components
- Severe immune-related adverse reactions from prior immunotherapy
- Primary immunodeficiency or active autoimmune disease
- History of organ transplant or kidney replacement therapy
- Irreversible interstitial lung disease (excluding radiation-induced)
- Having two or more malignant tumors, except certain cured cancers
- Uncontrolled hypertension or serious cardiovascular/cerebrovascular disease within 6 months
- Esophageal or gastric varices requiring immediate intervention or high bleeding risk
- Uncontrolled metabolic disorders or other serious non-malignant diseases
- Severe liver cirrhosis or failure
- Uncontrolled fluid buildup such as pleural effusion or ascites
- Serious organic diseases or mental illness
- Central nervous system metastasis
- Active systemic infection
- Recent or planned vaccination during study
- Participation in other drug clinical trials within 30 days
- Use of immunosuppressive drugs within 4 weeks before treatment
- Recent surgery, radiotherapy, chemotherapy, or immunotherapy within 2 weeks
- Positive for HIV, active hepatitis B or C, or syphilis
- Pregnant or breastfeeding women
- Poor compliance or inability to follow study protocol
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
Y
Yi Zhang, Doctor
CONTACT
G
Ge Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here