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

Last updated: June 26, 2024
Sponsor: Ting Deng
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

NW-301D

NW-301V

Clinical Study ID

NCT06484790
NW-301-001
  • Ages 18-75
  • All Genders

Study Summary

An open label, two cohorts, multiple dose exploratory clinical study to independently evaluate the safety, efficacy, and pharmacokinetics of autologous anti-KRAS G12V/G12D mutation T-cell Receptor T cell in advanced solid tumor

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

Total Participants: 9
Treatment Group(s): 2
Primary Treatment: NW-301D
Phase: 1
Study Start date:
April 08, 2024
Estimated Completion Date:
April 07, 2027

Study Description

this study is an open, two cohorts single infusion, dose escalation/dose regimen finding study to independently assess the safety and pharmacokinetics of KRAS G12V/G12D mutation TCR-T cell therapies, and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with KRAS G12V/G12D mutation and failed to standard systemic treatment.

Connect with a study center

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

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