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

NCT06478251 | Recruiting Phase 1

• 1 other identifier: NW-301-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumor, Solid

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT)

  Safety

  28 days post infusion

Secondary Outcomes (2)

• Objective response rate (ORR)

  Through study completion, an average of 2 year

• Duration of response (DOR)

  Through study completion, an average of 2 year

Study Arms (2)

NW-301V monotherapy in patients with Solid Tumors with KRAS G12V mutation

EXPERIMENTAL

Drug: NW-301V

NW-301D monotherapy in patients with Solid Tumors with KRAS G12D mutation

EXPERIMENTAL

Drug: NW-301D

Interventions

NW-301V DRUG

TCR-T cell targeting KRAS G12V mutation

NW-301V monotherapy in patients with Solid Tumors with KRAS G12V mutation

NW-301D DRUG

TCR-T cell targeting KRAS G12D mutation

NW-301D monotherapy in patients with Solid Tumors with KRAS G12D mutation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-75 years
• Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments
• HLA-A\*11:01positive
• Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation
• Adequate organ function prior to apheresis and lymphodepleting chemotherapy
• ECOG performance status of 0-1
• At least one tumor lesion measurable according to RECIST 1.1

You may not qualify if:

• Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpoint inhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion
• History of allergic reactions to cyclophosphamide, fludarabine, or any other chemical or biological components of the drugs used in this study
• History of chronic or recurrent severe autoimmune disease, or active immune disease requiring treatment with steroids or other immunosuppressive agents within 1 year prior 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

Sponsors & Collaborators

• TingBo Liang: lead
• Neowise Biotechnology: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhejiang University school of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Rui Liu

CONTACT

0512-67991566; rui.liu@neowisebio.com

Yuhui He

CONTACT

0512-67991566; yuhui.he@neowisebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)