Status:
RECRUITING
Genetically Modified T Cells Treating Malignant Tumors
Lead Sponsor:
Yi Zhang
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
To observe the safety, tolerability and initial effectiveness of gene modified T cell therapy in patients with malignant tumors in First Affiliated Hospital of Zhengzhou University, China.
Detailed Description
The study population included subjects with malignant tumors confirmed by histopathology or cytology, including: non-small cell lung cancer, esophageal squamous cell carcinoma, gastric cancer, colorec...
Eligibility Criteria
Inclusion
- Subjects with malignant tumors confirmed by histopathology or cytology, including: non-small cell lung cancer, esophageal squamous cell carcinoma, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer, kidney cancer, cervical squamous cell carcinoma, ovarian cancer, breast cancer, melanoma, and brain glia tumor, lymphoma, etc.;
- Age: 18 \~ 75 years old; Gender: no limitation;
- Have sufficient hematopoietic capacity: ANC \>1500 cells /mm3, Blood plate count \>50,000 cells /mm3, HGB \>9.0g/dL, ALC \>9 cells /mm3;
- Adequate liver and kidney function: AST and ALT ≤2.5 ULN in patients without liver metastasis and ≤5 times in patients with liver metastasis. ULN; Bilirubin ≤1.5 ULN (excluding hyperbilirubinemia or hyperbilirubin of non-hepatic origin); Creatinine ≤2.0 ULN. Creatinine clearance and creatinine clearance hormone ≥40 mL/min;
- PT/INR \<1.5 ULN, and PTT/αPTT \<1.5 ULN;
- For desirable tumor tissues or tissue white tablets, positive expression of at least one of Mesothelin, NKG2D, HER2, CD276, CD19, BCMA and other antigens can be selected for clinical trials;
- ECOG physical status score 0 \~ 2 points;
- Expected survival \>6 months;
- Subject accepts voluntarily
Exclusion
- Received anti-PD1, anti-PD-L1 or anti-PD-L2 antibody therapy or other immunotherapy methods one month before treatment with immune cells in this study;
- History of organ transplantation;
- Pregnancy or lactation;
- Positive for high baseline HBV DNA levels (≥2000 IU/ml), HIV antibodies (anti-HIV), hepatitis C virus antibodies (anti-HCV), or treponema pallidum antibodies;
- There is active infection;
- There are active brain metastases (except asymptomatic or stable brain metastases after treatment);
- Combined with a second tumor; With the exception of patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid cancer who achieved complete response to the second tumor for more than 5 years and did not require treatment during the study period;
- Severe autoimmune diseases such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, or Wegener's granulomatosis require long-term (more than 2 months) systemic immunosuppressive therapy;
- People with allergies;
- NYHA heart failure grade ≥2 or hypertension can not be controlled after standard treatment, have a history of myocarditis or have a heart attack within one year;
- Thrombotic diseases with active bleeding that require treatment;
- Patients who are determined by the researcher to have a serious uncontrollable disease or other conditions that may affect the treatment in this study and are considered unsuitable.
Key Trial Info
Start Date :
August 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06515626
Start Date
August 18 2024
End Date
December 1 2027
Last Update
September 25 2024
Active Locations (1)
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1
Zhengzhou University First Affiliated Hospital
Zhengzhou, Henan, China