Phase 1 Study of NW-301V TCR-T Cells in Advanced Solid Tumors With KRAS G12V Mutation

NCT07875920 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: NW-301V-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single-arm, multicenter, open-label, Phase 1a/1b dose-escalation and dose-expansion study designed to evaluate the safety, preliminary antitumor activity, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of NW-301V, an autologous TCR-T cell therapy, in Chinese adult participants with advanced malignant solid tumors harboring a KRAS G12V mutation.

Conditions

Advanced Solid Cancer; Pancreatic Ductal Adenocarcinoma (PDAC); Colorectal Adenocarcinoma; Lung Adenocarcinoma; KRAS G12V; Pancreatic Cancer; Colorectal Cancer

Keywords

TCR-T; TCR-T cell therapy; PDAC; CRC; LUAD; Pancreatic cancer; Colorectal cancer; NSCLC; KRAS; KRAS G12V; HLA-A*11:01; Solid tumors

Outcome Measures

Primary Outcomes (4)

• Phase 1a: Safety and tolerability of NW-301V in participants with advanced solid tumors

  Type, frequency, and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), abnormalities in vital signs, electrocardiograms (ECGs) and other laboratory results.

  Through the study completion, an average of 2 years

• Phase 1a: Maximum tolerated dose (MTD, if applicable) and provisional Recommended Phase 2 Dose (RP2D)

  Number of participants with dose-limiting toxicities (DLTs) and their types.

  28 days

• Phase 1b: Safety and tolerability of NW-301V in PDAC, CRC and LUAD respectively under provisional RP2D

  Type, frequency, and severity of TEAEs, SAEs, and abnormalities in vital signs, ECGs and other laboratory results.

  Through the study completion, an average of 2 years

• Phase 1b: Final RP2D of NW-301V

  Determine the final RP2D of NW-301V

  Up to 2 years

Secondary Outcomes (8)

• Objective response rate (ORR)

  Through the study completion, an average of 2 years

• Disease control rate (DCR)

  Through the study completion, an average of 2 years

• Duration of response (DOR)

  Through the study completion, an average of 2 years

• Progression-free survival (PFS)

  Through the study completion, an average of 2 years

• Overall survival (OS)

  Through the study completion, an average of 2 years

Study Arms (1)

NW-301V

EXPERIMENTAL

Participants receive lymphodepletion and a single infusion of NW-301V, an autologous TCR-T cell therapy targeting KRAS G12V. In Phase 1a (dose escalation), two dose levels at 4×10\^9 (±30%) and 8×10\^9 (±30%) TCR-T+ cells will be tested. In Phase 1b (dose expansion), NW-301V will be administered at provisional RP2D in 3 tumor-specific cohorts (Cohort A: pancreatic ductal adenocarcinoma; Cohort B: colorectal adenocarcinoma; Cohort C: lung adenocarcinoma), each containing around 20 participants.

Drug: Fludarabine; Drug: Cyclophosphamide; Biological: NW-301V

Interventions

Fludarabine DRUG

Used for lymphodepletion

NW-301V

Cyclophosphamide DRUG

Used for lymphodepletion

NW-301V

NW-301V BIOLOGICAL

NW-301V is an autologous TCR-T cell therapy targeting KRAS G12V in the context of HLA-A\*11:01, administered intravenously after lymphodepletion.

NW-301V

Eligibility Criteria

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

You may qualify if:

• Applicable to both Phase 1a and 1b:
• Age between 18-75 years
• HLA-A\*11:01 positive
• Tumor confirmed to have KRAS G12V mutation
• At least one measurable lesion according to RECIST 1.1
• ECOG 0-1
• Life expectancy \> 3 months before leukapheresis
• Adequate organ functions prior to leukapheresis and lymphodepletion
• For Phase 1a only:
• Histologically or pathologically confirmed, advanced or unresectable solid tumors including, but not limited to, pancreatic ductal adenocarcinoma (PDAC), colorectal adenocarcinoma (CRC), and lung adenocarcinoma (LUAD)
• Participants must have no standard treatment options available or are unable to tolerate currently available standard treatment
• For Phase 1b only:
• Cohort A: Histologically or pathologically confirmed advanced or locally advanced unresectable PDAC that had failed or progressed after at least 1 line of prior systemic therapy
• Cohort B: Histologically or pathologically confirmed advanced CRC that had failed or progressed after at least 2 lines of prior systemic therapies
• Cohort C: Histologically or pathologically confirmed advanced LUAD that had failed or progressed after at least 1 line of prior systemic therapy

You may not qualify if:

• Applicable to both Phase 1a and 1b:
• Received the following treatments: Cytotoxic chemotherapy or immunosuppressive agents within 2 weeks prior to leukapheresis, or within 1 week prior to lymphodepletion; Antibodies or other biologic therapy within 3 weeks prior to leukapheresis, or within 2 weeks 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 leukapheresis or lymphodepletion
• Have symptomatic CNS metastases
• Have leptomeningeal disease or carcinomatous meningitis
• Have ongoing or active infection
• Breastfeeding or pregnant

Sponsors & Collaborators

• Neowise Biotechnology: lead

Study Sites (2)

Beijing Cancer Hosptial

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung; Pancreatic Neoplasms; Colorectal Neoplasms

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Rui Liu, Master Degree

CONTACT

+86-512-67991566; rui.liu@neowisebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2033
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

CN (2)