T-cell therapy for patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, efficacy, and pharmacokinetics of a novel T-cell therapy targeting KRAS G12V/G12D mutations in patients with advanced solid tumors. It involves an open-label, two-cohort design with a focus on patients who have not responded to standard systemic treatments. Participants will receive a single infusion of the therapy, and the study aims to gather preliminary efficacy results alongside safety data. The trial is designed for patients with specific types of cancer, including pancreatic, colorectal, and lung adenocarcinoma.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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

(Additional protocol-defined Inclusion criteria may apply.)

Key Exclusion Criteria:

* 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.)

Where it's running

• Wuhan Union Hospital
  Wuhan, Hubei, China Recruiting
• Wuhan Union Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Rui Liu
• Email: rui.liu@neowisebio.com
• Phone: 15377559472

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.