T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor

Last updated: November 19, 2025
Sponsor: Ting Deng
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

NW-301D

NW-301V

Clinical Study ID

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

Study Summary

An open label, two-cohort, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics/pharmacodynamic (PK/PD) of NW-301V and NW-301D in subjects with advanced solid tumor.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Age between 18-75 years

  • Diagnosis of pathologically or histologically confirmed unresectable or advancedsolid tumor, and have no standard treatment options available or unable to toleratethe currently available standard treatments

  • HLA-A11:01positive Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort)mutation * Adequate organ function prior to apheresis and lymphodepletingchemotherapy

  • ECOG performance status of 0-1

  • At least one tumor lesion measurable according to RECIST 1.1 (Additionalprotocol-defined Inclusion criteria may apply.)

Exclusion

Key Exclusion Criteria:

  • Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior toapheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpointinhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurininhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil,rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, oranti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week prior tolymphodepletion

  • History of allergic reactions to cyclophosphamide, fludarabine, or any otherchemical or biological components of the drugs used in this study

  • History of chronic or recurrent severe autoimmune disease, or active immune diseaserequiring treatment with steroids or other immunosuppressive agents within 1 yearprior to enrollment* Have symptomic CNS metastases

  • Have leptomeningeal disease or carcinomatous meningitis

  • Have ongoing or active infection

  • Active infections with HIV, HBV, HCV, or syphilis

  • Breastfeeding or pregnant (Additional protocol-defined Exclusion criteria mayapply.)

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

Using a modified 3+3 dose escalation design, this study will enroll ~9subjects to characterize the safety and preliminary anti-tumor activity of NW-301V and NW-301D in each cohort respectively. Eligible subjects will undergo leukapheresis for autologous cell product manufacturing, and will receive a 3-day lymphodepleting regimen consisting of cyclophosphamide and fludarabine, followed by a single-dose intravenous infusion of NW-301V or NW-301D. after NW-301V or NW-301D infusion, a low dose of IL-2 will be given subcutaneously for up to 10 days. following this intervention, subjects will be monitored for safety and AE, and tumor evaluation will be performed at pre-specified timepoints per protocol.

Connect with a study center

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin 1792947, Tianjin Municipality 1792943
    China

    Active - Recruiting

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