Clinical trialEarly Phase 1Recruiting
Genetically Modified T Cells Treating Malignant Tumors
Clinical Study to Evaluate the Safety and Efficacy of Genetically Modified T Cells in the Treatment of Malignant Tumors
- Outcome
- Ongoing
- Phase
- Early Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 18 August 2024
- Expected end
- December 2027
- Enrollment
- 100 participants
- Sites
- 1
- Primary outcomes
- PFS
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 25 September 2024
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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, colorectal cancer, liver cancer, pancreatic cancer, kidney cancer, cervical squamous cell carcinoma, ovarian cancer, breast cancer, melanoma, brain glioma, lymphoma, etc. The study is aimed to observe the safety, tolerability and initial effectiveness of gene modified T cell therapy in patients with malignant tumors.To observe Progression-Free Survival (PFS) and Overall survival (OS) after the application of gene modified T cell therapy in patients with malignant tumors, and to evaluate the Disease Control Rate (Disease Control Rate). DCR, Clinical Benefit Rate (CBR), Quality of Life (QOL).And explore the diversity of T cell receptors and proportion of lymphocyte subsets in subjects treated with gene-modified T cell therapy for malignant tumors changes in distribution and count, immune cell function, and serum cytokine levels.