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

NCT06956261 | Not Yet Recruiting Phase 1

• 1 other identifier: NW-301-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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

Conditions

Tumor, Solid

Keywords

TCR-T; KRAS; G12V; G12D

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT)

  safety

  28 days of single infusion

Study Arms (2)

Experimental : NW-301V

EXPERIMENTAL

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

Drug: NW-301V

Experimental : NW-301D

EXPERIMENTAL

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

Drug: Drug: NW-301D

Interventions

NW-301V DRUG

TCR-T T cell targeting KRAS G12V mutation

Experimental : NW-301V

Drug: NW-301D DRUG

TCR-T T cell targeting KRAS G12D mutation

Experimental : NW-301D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (2)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 100000, China

Location

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Changsong Qi, Doctor

CONTACT

13811394004; xiwangpku@126.com

Study Design

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

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 4, 2025
• Study Start: May 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

CN (2)