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New treatment option for Pancreatic Cancer
Official title TCR-T Cell Therapy on Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05438667
What this study is testing
What is TCR-T therapy?
TCR-T therapy is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age greater than 18 years old；
- people with advanced solid tumors confirmed by histology/cytology who have failed standard treatment, are intolerant to standard treatment, or for...
- Previous tissue pathology or peripheral blood testing confirmed the presence of KRAS G12V or G12D mutations with matching HLA subtypes；
- Expected survival duration of more than 3 months；
- Eastern Cooperative Oncology Group( ECOG )score ≤2；
You likely can't join 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...
See the full eligibility criteria
- Age greater than 18 years old；
- people with advanced solid tumors confirmed by histology/cytology who have failed standard treatment, are intolerant to standard treatment, or for whom no standard treatment exists. . Non-small cell lung cancer...
- Previous tissue pathology or peripheral blood testing confirmed the presence of KRAS G12V or G12D mutations with matching HLA subtypes；
- Expected survival duration of more than 3 months；
- Eastern Cooperative Oncology Group( ECOG )score ≤2；
- All participants voluntarily participate in this study and sign an informed consent. And the people have good compliance and can cooperate with investigators follow-up study.
- Patients at least have had at least one measurable lesion as defined by RECIST v1.1 criteria；
- Female participants can not be pregnant or lactating and their serum or urine human chorionic gonadotropin tests must be negative within 72 hours prior to study enrollment；All people must be using a medically accepted...
- Organ function and bone marrow reserve are in good condition, and the following requirements must be met: 1)Absolute neutrophil count≥1.5×10⁹/L, Absolute lymphocyte count ≥0.5×10⁹/L；2)Platelet...
- 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...
- 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 people ;
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.