Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06484790

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

Led by Ting Deng · Updated on 2025-11-25

9

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

T

Ting Deng

Lead Sponsor

N

Neowise Biotechnology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Key

  • 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-A11:01positive 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 (Additional protocol-defined Inclusion criteria may apply.)

Key

Not Eligible

You will not qualify if you...

  • 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 (Additional protocol-defined Exclusion criteria may apply.)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

Loading map...

Research Team

R

Rui Liu

CONTACT

Y

Yuhui He

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here