TCR-T Cell Therapy on Advanced Solid Tumors
Recruiting now · Early Phase 1
Conditions studied: Pancreatic Cancer
In brief
The primary aim of this study is to evaluate the efficacy of KRAS mutant antigen specific TCR-T cells in the treatment of patients with advanced solid tumors. The secondary aim is to evaluate the pharmacokinetic/pharmacodynamic characteristics of TCR-T cell therapy in patients with advanced solid tumors and the survival of TCR-T cells. The investigators will evaluate the changes of tumor microenvironment after treatment of advanced solid tumors with KRAS mutant antigen specific TCR-T cells; Evaluating the correlation between cytokines and the occurrence of CRS and neurotoxicity
Key facts
- Study ID
- NCT05438667
- Run by
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- People needed
- 18
- Starts
- 2023-06-01
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2025-09-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Intracranial metastasis or Patients with moderate or severe hydrothorax need drain placement to relieve symptoms.
- Active pulmonary tuberculosis
- Human immunodeficiency virus (HIV) positive；
- Active Hepatitis B or Hepatitis C infection；
- Pregnant women and lactating females；
- Previous or concurrent history of other malignant tumors. Exceptions include curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy;
- Patients with central nervous metastases；
- Serious, uncontrolled comorbidities that may affect protocol compliance or interfere with interpretation of results，or any serious medical condition that may affect the safety of the subjects ;
- History of clinically significant respiratory diseases or other respiratory diseases that seriously affect Pulmonary function;
- Any active autoimmune disease,any condition requiring steroid hormones or immunosuppressive therapy( including but not limited to systemic lupus erythematosus, sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc., require > 10 mg/D of prednisone or equivalent hormone）
- A history of organ transplantation；
- A history of myocardial infarction and severe arrhythmia within six months；Ineligible also includes uncontrolled hypertension, coronary heart disease, stroke, liver cirrhosis, nephritis and other serious complications;
- Those who have a history of psychotropic drug abuse and cannot quit or have a history of psychiatric impairment；
- Participants with an allergic constitution, known sensitivity to human serum albumin, cyclophosphamide, fludarabine and interleukin 2;
- Those with bleeding or thromboembolic tendency：bleeding symptoms of clinical significance or a clear tendency to bleeding within 2 weeks prior to entering the study. And those with hereditary or acquired bleeding and thrombotic tendencies； serious arterial/venous thromboembolic events occurred in the previous 6 months;
- Other severe, acute or chronic medical or mental illnesses that in the investigator's judgement will might be increase the risk associated with the patient's participation in the study or interfere with interpretation of research results.
Where it is running
- Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.