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
This study is testing a new treatment using specially designed T cells to see if it can help people with advanced solid tumors that haven't responded to other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy, methotrexate, cyclophosphamide, fludarabine |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06484790 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 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, colorectal, or lung adenocarcinoma who have failed or cannot tolerate standard systemic treatments.
Not a fit: Patients without KRAS G12V or G12D mutations or those with tumors not classified as advanced 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: While this approach is innovative, similar studies targeting specific mutations in solid tumors 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-A11:01positive 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
Tianjin, Tianjin Municipality
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, 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.