T-cell therapy for patients with advanced solid tumors
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
This study is testing a new T-cell therapy for patients with advanced solid tumors, like pancreatic and lung cancer, who haven't had success with other treatments to see if it can help them.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Drugs / interventions | chemotherapy, methotrexate, cyclophosphamide, fludarabine |
| Locations | 2 sites (Wuhan, Hubei and 1 other locations) |
| Trial ID | NCT06484556 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced solid tumors, specifically pancreatic, colorectal, or lung adenocarcinoma, who have failed or cannot tolerate standard treatments.
Not a fit: Patients without KRAS G12V or G12D mutations or those with other types of solid tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors that harbor KRAS mutations.
How similar studies have performed: While this approach is innovative, similar studies targeting KRAS mutations have shown promise, indicating potential for success.
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
Wuhan, Hubei and 1 other locations
- 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
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.