Genetically Modified T Cells Treating Malignant Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYi Zhang
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- CAR-T cell reinfusion
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Yi Zhang
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Sponsor institution
Source ClinicalTrials.gov