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

NCT07266298 | Recruiting Phase 1 DMC

• 1 other identifier: NW-101C-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Solid Metastatic Tumor

Outcome Measures

Primary Outcomes (2)

• Evaluate the Dose-limiting toxicities(DLTs) of NW-101C in patients with solid malignant tumors

  Type, frequency and severity of adverse events assessed by CTCAE5.0

  28 days following NW-101C infusion

• Evaluate the Maximum Tolerated Dose (MTD) of NW-101C in patients with solid malignant tumors

  Type, frequency and severity of adverse events assessed by CTCAE5.0

  Through the study completion, an average of 2 years

Secondary Outcomes (4)

• Evaluate the AUC of NW-101C in patients with solid malignant tumors

  2 years following NW-101C infusion

• Evaluate the Objective response rate (ORR) of NW-101C in patients with solid malignant tumors

  2 years following NW-101C infusion

• Evaluate the Cmax of NW-101C in patients with solid malignant tumors

  Through the study completion, an average of 2 years

• Evaluate the Tmax of NW-101C in patients with solid malignant tumors

  Through the study completion, an average of 2 years

Study Arms (1)

NW-101C dose 1-4

EXPERIMENTAL

Biological: NW-101C

Interventions

NW-101C BIOLOGICAL

4 dosage of NW-101C will be tested in this study using classic 3+3 dose escalation approach: 4×10\^8±30%, 8×10\^8±30%,15×10\^8±30% and 30×10\^8±30% TCR-T+ cells

NW-101C dose 1-4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Neowise Biotechnology: lead

Study Sites (1)

Beijing Cancer hosptial

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Yuhui He

CONTACT

0512-67991566; yuhui.he@neowisebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A classic 3+3 model will be used to dose escalation,4 doses will be used: 4×10\^8±30%, 8×10\^8±30%, 15×10\^8±30% and 30×10\^8±30% TCR-T cells/ patients

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)