advanced solid tumors
Conditions
Interventions
Group 1:PM3006
Group 2:PM3006
Sponsors
The First Affiliated Hospital,College of Medicine,Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures; 2.Male or female aged 18 to 70 years; 3.Histologically confirmed with mesothelin positive advanced malignant solid tumors; 4.All subjects are required to provide tumor tissue specimens that can be used for Mesothelin analysis; 5.All acute toxicity from prior antitumor therapy is reduced to level 0-1(According to NCI CTCAE version 5.0) or to an acceptable level for inclusion/exclusion criteria; 6.Adequate organ function, as defined below(In the absence of medical support such as blood transfusion or granulocyte colony-stimulating factor within 14 days prior to cell reinfusion): Blood system: Neutrophil count (ANC) >=1.5x10^9/L; white blood cells >= 3.0×10^9/L Platelet count (PLT) >= 100x10^9/L; Hemoglobin (Hb) >= 90g/L;Liver function: Total bilirubin (TBIL) = 50ml/min; urinary protein= 2+, 24 hour urinary protein quantitative examination is required; if 24 hour urinary protein quantitative examination =12 weeks; 9.Subjects must have measureable disease as defined by RECIST 1.1 standard; 10.After evaluation, sufficient PBMC cells could be collected from the subjects to prepare the MSLN-targeted CAB-T cells; 11.After evaluation, the prepared backtransfusion cells are adequate quantity and qualified quality, which can be used for clinical treatment; 12.Pre-menopausal female subjects who have negative blood pregnancy results before study therapy should agree to abstain from sex or to use medically approved effective contraceptive methods (such as intrauterine devices , contraceptives or condoms) starting with the date of signing the informed consent through 6 months after the last dose of study; 13.Male subjects are agree to abstain from sex or use medically approved effective contraceptive methods for 5 months from the date of signing the informed consent form to the end of the last medication, and do not donate sperm during this period;
Exclusion criteria
Exclusion criteria: 1.History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study; 2.Received gene therapy or cell therapy or tumor vaccine; 3.Received coronary artery reconstruction surgery; 4.Evidence of severe coagulation disorders or other significant bleeding risk: a)Past history of intracranial hemorrhage or spinal cord hemorrhage; b)Subjects with tumor lesions invading large vessels and with significant risk of bleeding; c)Thrombosis or embolism event occurred within 6 months before infusion; d)Clinical significant hemoptysis or tumor hemorrhage occurred within 1 month before infusion; e)Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) was used within 2 weeks prior to infusion; f)10 days prior to infusion, use of antiplatelet medication, such as aspirin (>;325 mg/ day), clopidogrel (>;75 mg/ day), dipyridamole, ticlopidine or cilotazole, etc.; 5.The following treatments or drugs were administered prior to the treatment of the study: a)Unhealed wounds, ulcers, or fractures within 28 days prior to infusion; b)Live attenuated vaccine was administered within 28 days prior to infusion; c)Have received chemotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor therapies (except for those prescribed in accordance with the protocol before infusion) or any unmarketed investigational drug within 28 days prior to infusion; The following conditions were also excluded: treatment with nitrosourea or mitomycin C within 6 weeks prior to infusion; Received oral fluorouracil and small-molecule targeted drug therapy 2 weeks before infusion or within 5 half-lives of the drug, whichever is the longer; received traditional Chinese medicine treatment with anti-tumor indications 2 weeks prior to infusion; d)During the 2 weeks prior to infusion, patients received systemic intravenous antimicrobial therapy; e)Have received corticosteroids within 2 weeks prior to infusion, or anticipated that corticosteroid therapy might be required during blood collection, cell collection, or cell reinfusion; Except in the following cases: Dose of prednisone no higher than 10 mg/d prednisone for a short period of time ( 480 msec, clinical significant arrhythmia and need interventions, myocardial troponin > 2.0 ULN, poorly controlled diabetes or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT occurred within 28 days after first administration;ORR; | — |
Countries
China
Contacts
Public ContactWeijia Fang
The First Affiliated Hospital, College of Medicine,Zhejiang University
Outcome results
None listed