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

NCT ID: NCT06956261

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-10
• Study Completion Date: 2027-12-31

Brief 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

Detailed 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

Conditions

Tumor, Solid

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental : NW-301V

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

Group Type: EXPERIMENTAL

NW-301V

Intervention Type: DRUG

TCR-T T cell targeting KRAS G12V mutation

Experimental : NW-301D

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

Group Type: EXPERIMENTAL

Drug: NW-301D

Intervention Type: DRUG

TCR-T T cell targeting KRAS G12D mutation

Interventions

NW-301V

TCR-T T cell targeting KRAS G12V mutation

Intervention Type: DRUG

Drug: NW-301D

TCR-T T cell targeting KRAS G12D mutation

Intervention Type: DRUG

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).

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Changsong Qi, Doctor

Role: CONTACT

xiwangpku@126.com

13811394004

Other Identifiers

NW-301-001

Identifier Type: -

Identifier Source: org_study_id