Safety and Efficacy Evaluation of MUC-1 CART in the Treatment of Intrahepatic Cholangiocarcinoma (NCT03633773) | Clinical Trial Compass
UnknownPhase 1/2
Safety and Efficacy Evaluation of MUC-1 CART in the Treatment of Intrahepatic Cholangiocarcinoma
China9 participantsStarted 2018-07-01
Plain-language summary
Intrahepatic cholangiocarcinoma (ICC) is one of the most common liver malignancies. Surgical treatment is the first choice. However, for patients without surgical indications, the benefits of conventional chemoradiotherapy are limited. CART is one of the fastest developed treatments in recent years. MUC-1 CART can target abnormal glycosylation of MUC-1 and then killing tumor specifically. Here, investigators intend to evaluate the safety and efficacy of MUC-1 CART in intrahepatic cholangiocarcinoma.
Who can participate
Age range18 Years ā 65 Years
SexALL
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Inclusion criteria
ā. Age 18-65 years old.
ā. The expression of ST glycosylated MUC-1 was more than 1+ in immunohistochemistry(IHC) by applicant-approved laboratory.
ā. Histopathology or cytology confirmed intrahepatic cholangiocarcinoma.
ā. Patients who are unable to perform surgery or are not suitable for surgery, or who have recurrence after surgery, or who are unwilling to undergo chemotherapy.
ā. With at least one extracranial measurable lesion according to RECIST 1.1 edition.
ā. The expected survival time is more than 60 days.
ā. The main organs are functional and meet the following criteria:
Exclusion criteria
ā. The transduction efficiency of T cells was \<10% or T cells expanded less than 5 times after culture.
ā. Chimeric antigen receptor therapy or other transgenic T cell therapy.
ā. Pregnant or lactating women.
ā. In the first 4 weeks before the start of the study, they took part in other drug clinical trials.
ā. Patients with hypertension who can not be well controlled by a single antihypertensive drug (SBP\> 140 mmHg, DBP\> 90 mmHg), myocarditis or congenital heart disease, myocardial ischemia or infarction above grade I, arrhythmia above grade I (including QT interval \< 440 ms) or cardiac insufficiency.
What they're measuring
1
Disease control rate
Timeframe: Up to approximately 12 months
Trial details
NCT IDNCT03633773
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
ā. With a history of psychotropic substance abuse and unable to quit or have a history of mental disorders.
ā. Past and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.