Actively Recruiting
TCR-engineered T Cells (NW-101C) in Patients With Solid Malignant Tumors
Led by Neowise Biotechnology · Updated on 2025-12-12
24
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is a prospective, dose-escalation, multicenter, single- arm, Phase 1 clinical trial to evaluate the safety, tolerability, PK and preliminary clinical activity of PRAME Antigen-targeted TCR-T Cells (NW-101C) infusion in patients with previously heavily treated, metastatic solid malignant tumors.
CONDITIONS
Official Title
TCR-engineered T Cells (NW-101C) in Patients With Solid Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumors with no standard treatment options or intolerance to available treatments
- For ovarian cancer patients: confirmed diagnosis of platinum-resistant ovarian epithelial carcinoma
- Positive for HLA-A*02:01
- Tumor expresses PRAME antigen as assessed by a central laboratory
- Adequate organ function prior to leukapheresis and lymphodepleting chemotherapy
- ECOG performance status of 0 or 1
- At least one measurable tumor lesion according to RECIST 1.1
- Additional protocol-defined inclusion criteria may apply
You will not qualify if you...
- Received cytotoxic chemotherapy within 2 weeks before leukapheresis or within 1 week before lymphodepletion
- Received antibodies or other biologic therapy within 2 weeks before leukapheresis or within 1 week before lymphodepletion
- Taken immunosuppressive agents within 2 weeks before leukapheresis or within 1 week before lymphodepletion
- History of allergic reactions to cyclophosphamide, fludarabine, or related drug components
- History of chronic or recurrent severe autoimmune disease or active immune disease requiring steroids or immunosuppressives within 1 year prior to enrollment
- Symptomatic central nervous system metastases
- Presence of leptomeningeal disease or carcinomatous meningitis
- Ongoing or active infections
- Active infections with HIV, HBV, HCV, or syphilis
- Pregnant or breastfeeding
- Additional protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer hosptial
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Y
Yuhui He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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