Phase
Condition
N/ATreatment
NW-301D
NW-301V
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18 to 75 years, male or female; Subjects with pathologically confirmedPancreatic Cancer and Colorectal Cancer and Lung Adenocarcinoma Cancer and have beenfailed to stand of care systemic treatment or have been untolerated to stand of caresystemic treatment; HLA-A*11:01 positive Tumor tissue samples. sample was positivefor KRAS G12V or G12D mutation; Estimated life expectancy > 12 weeks; According tothe RECIST 1.1, there is at least one measurable tumor lesion; ECOG physical statusscore 0 ~ 1; Sufficient venous access for mononuclear cell collection (abbreviation:apheresis) Subjects should have adequate organ functions before screening andpre-treatment (at baseline).
Female subjects of childbearing age must undergo a serum pregnancy test at screening and prior to preconditioning and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment. The methods that can be used are: bilateral tubal ligation / bilateral salpingectomy or bilateral tubal occlusion; or approved oral, injection or hormone-imparting contraceptive methods; or barrier contraceptive method: containing spermicidal foam / Gel/film/cream/suppository condom or occlusive cap (diaphragm or cervix/cap); Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy, for example, a condom containing a spermicidal foam/gel/film/paste/suppository, or use a contraceptive method for their spouse (see article 9 of the inclusion criteria). Moreover, all men are absolutely forbidden to donate sperm within 1 year after receiving the last study treatment infusion; Subject participates in this clinical trial and sign Informed Consent Form voluntarily.
Exclusion
Exclusion Criteria:
- Received the following therapy/treatment : Cytotoxic chemotherapy within 1 weekprior to leukapheresis or lymphodepleting chemotherapy , Immune therapy (includingmonoclonal antibody therapy, checkpoint inhibitors) within 2 weeks prior toleukapheresis and within 1 week prior to lymphodepleting chemotherapyCorticosteroids within 2 weeks prior to leukapheresis and within 72 hrs prior tolymphodepleting chemotherapy Immunosuppressive drugs within 2 weeks prior toleukapheresis and within 1 week prior to lymphodepleting chemotherapy Tyrosinekinase inhibitor (TKI) (e.g. pazopanib) within 1 week prior to leukapheresis andwithin 1 week prior to lymphodepleting chemotherapy KRAS G12V mutation targettedtherapy prior to leukapheresis and lymphodepleting chemotherapy in KRAS G12Vmutation cohort KRAS G12D mutation targetted therapy prior to leukapheresis andlymphodepleting chemotherapy in KRAS G12D mutation cohort Anti-cancer Vaccine, Genetherapy using an integrating vector , Investigational treatment or interventionalclinical trial prior to leukapheresis and lymphodepleting chemotherapy Major surgeryprior to leukapheresis History of allergic reactions attributed to compounds ofsimilar chemical or biologic composition to fludarabine, cyclophosphamide or otheragents used in the study.
History of autoimmune or immune mediated disease Symptomatic CNS metastases including leptomeningeal disease. Other prior malignancy that is not considered by the Investigator to be in complete remission Clinically significant cardiovascular disease Uncontrolled intercurrent illness Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus Pregnant or breastfeeding
Study Design
Study Description
Connect with a study center
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin
ChinaActive - Recruiting
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