PRAME-targeted T-cell (NW-101C) therapy for metastatic solid tumors
A Phase I, Multicenter, Dose-escalation, Single-arm Study of PRAME Antigen-targeted TCR-T Cells(NW-101C) in the Treatment of Subjects With Advanced Solid Malignant Tumors.
This trial will test whether a patient's own PRAME-directed T cells (NW-101C) are safe and show early anti-tumor activity in people with HLA-A*02:01 metastatic solid tumors who have had many prior treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Neowise Biotechnology Industry-sponsored |
| Drugs / interventions | chemotherapy, methotrexate, cyclophosphamide, fludarabine |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07266298 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, single-arm Phase 1 dose-escalation trial using a classic 3+3 design to define safety and preliminary activity of NW-101C, an autologous PRAME-targeted TCR-T product. Patients undergo HLA and tumor PRAME testing, leukapheresis to collect white blood cells for manufacturing, and lymphodepleting chemotherapy with cyclophosphamide and fludarabine before infusion. Participants are admitted for the T-cell infusion and monitored in hospital through 28 days post-infusion for dose-limiting toxicities, with pharmacokinetic and safety endpoints guiding dose escalation. About 24 subjects will be enrolled to characterize tolerability, PK, and early signs of anti-tumor effect.
Who should consider this trial
Good fit: Adults 18–75 with unresectable or metastatic solid tumors that express PRAME, who are HLA-A*02:01 positive, have ECOG 0–1, adequate organ function, measurable disease, and no standard treatment options are ideal candidates.
Not a fit: Patients who lack HLA-A*02:01, whose tumors are PRAME-negative, who have poor organ function or ECOG >1, or who cannot undergo leukapheresis or lymphodepletion are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this therapy could shrink tumors or slow disease progression in some patients whose cancers no longer respond to standard treatments.
How similar studies have performed: Engineered TCR-T approaches against shared tumor antigens have produced occasional responses in early trials, but PRAME-directed TCR-T remains relatively novel with limited published clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18-75 years * Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumors and must have no standard treatment options available or unable to tolerate the currently available standard treatments * For patients with ovarian caner :Patients must have confirmed diagnosis of Platinum-resistant ovarian epithelial carcinoma(PROC) * HLA-A\*02:01positive * Patient's tumor must express PRAME assessed by central lab,Retrospective testing will be required for patients that qualify. * 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) 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
Beijing, Beijing Municipality
- Beijing Cancer hosptial — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yuhui He
- Email: yuhui.he@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.