TCR-engineered T Cells (NW-101C) in Patients With Solid Malignant Tumors

Recruiting now · Phase 1

Conditions studied: Solid Metastatic Tumor

In brief

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.

Key facts

Study ID

NCT07266298

Run by

Neowise Biotechnology

People needed

24

Starts

2025-12-01

Expected to finish

2030-12-01

Last updated by the study team

2025-12-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• Beijing Cancer hosptial — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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