NW-301 TCR-T in Patients With Advanced Solid Tumor

Launched by PEKING UNIVERSITY · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial, called NW-301, is exploring a new treatment for adults with advanced solid tumors, specifically targeting certain mutations found in cancers like pancreatic, colorectal, and lung cancer. The treatment involves using the patient's own T-cells (a type of immune cell) that are modified to recognize and attack cancer cells with specific KRAS mutations (G12V or G12D). The main goals of the study are to assess how safe this treatment is and how well it works.

To participate, individuals must be between 18 and 75 years old and have been diagnosed with one of the specified cancers that hasn’t responded to standard treatments or where those treatments were not tolerated. They also need to have specific tumor tissue characteristics and a life expectancy of more than 12 weeks. Participants will undergo a procedure to collect their T-cells before receiving the treatment. It's important for potential participants to understand that they will need to meet certain health criteria and follow guidelines regarding contraception if they are of childbearing age. This trial is still in the early stages and is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18 to 75 years, male or female; Subjects with pathologically confirmed Pancreatic Cancer and Colorectal Cancer and Lung Adenocarcinoma Cancer and have been failed to stand of care systemic treatment or have been untolerated to stand of care systemic treatment; HLA-A\*11:01 positive Tumor tissue samples. sample was positive for KRAS G12V or G12D mutation; Estimated life expectancy \> 12 weeks; According to the RECIST 1.1, there is at least one measurable tumor lesion； ECOG physical status score 0 \~ 1; Sufficient venous access for mononuclear cell collection (abbreviation: apheresis) Subjects should have adequate organ functions before screening and pre-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 Criteria:
• • Received the following therapy/treatment : Cytotoxic chemotherapy within 1 week prior to leukapheresis or lymphodepleting chemotherapy , Immune therapy (including monoclonal antibody therapy, checkpoint inhibitors) within 2 weeks prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy Corticosteroids within 2 weeks prior to leukapheresis and within 72 hrs prior to lymphodepleting chemotherapy Immunosuppressive drugs within 2 weeks prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy Tyrosine kinase inhibitor (TKI) (e.g. pazopanib) within 1 week prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy KRAS G12V mutation targetted therapy prior to leukapheresis and lymphodepleting chemotherapy in KRAS G12V mutation cohort KRAS G12D mutation targetted therapy prior to leukapheresis and lymphodepleting chemotherapy in KRAS G12D mutation cohort Anti-cancer Vaccine, Gene therapy using an integrating vector , Investigational treatment or interventional clinical trial prior to leukapheresis and lymphodepleting chemotherapy Major surgery prior to leukapheresis History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents 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