Treatment for advanced solid tumors using engineered T cells
An Open-Label, Dose-Escalation Phase I Clinical Study of T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
PHASE1 · Zhejiang University · NCT06478251
This study is testing a new treatment using specially engineered T cells to see if it can help people with advanced solid tumors that haven't responded to other therapies.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang University (other) |
| Drugs / interventions | chemotherapy, methotrexate, cyclophosphamide, fludarabine |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06478251 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, efficacy, and pharmacokinetics of a novel T-cell therapy targeting the KRAS G12V/G12D mutation 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 autologous T cells engineered to recognize specific tumor mutations, with the study aiming to gather preliminary efficacy results alongside safety data.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with advanced pancreatic or colorectal cancer who have failed or cannot tolerate standard treatments and have the KRAS G12V or G12D mutation.
Not a fit: Patients without the KRAS G12V or G12D mutation or those with other types of solid tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that harbor specific KRAS mutations.
How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital of Zhejiang University school of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Rui Liu
- Email: rui.liu@neowisebio.com
- Phone: 0512-67991566
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tumor, Solid