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

Study Overview

• Status: Recruiting
• Conditions: Solid Metastatic Tumor
• Intervention / Treatment: Biological: NW-101C

Detailed Description

Using a classic 3+3 dose escalation design, this study will enroll ~24 subjects to characterize the safety and preliminary anti-tumor activity of NW-101C.

SCREENING: Patient eligibility will be determined by protocol inclusion/exclusion criteria including HLA (human leukocyte antigen) and a biopsy (or collection of archival tumor tissue) for biomarker screening. Leukapheresis for potential manufacturing of the NW-101C cellular product may be performed,if patients are HLA-A*02:01 positive and meet the eligibility criteria for leukapheresis.

MANUFACTURING: NW-101C products will be made from the patients' white blood cells.

TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the NW-101C product infusion to improve the duration of time that NW-101C product stays in the body. The patient will be admitted to the hospital during the T-cell infusion until 28 days following NW-101C infusion. After the NW-101C product infusion, dose -limiting toxicities (DLT) will be assessed from the infusion of NW-101C until 28 days following the infusion of NW-101C.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yuhui He; Phone Number: 0512-67991566; Email: yuhui.he@neowisebio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Beijing Cancer hosptial
      • Contact: Lin Shen, Medical Doctor; Phone Number: 010-88121122; Email: doctorshenlin@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NW-101C dose 1-4	Biological: NW-101C; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the AUC of NW-101C in patients with solid malignant tumors	Area under the Plasma concentration versus time curve(AUC) assessed centrally	2 years following NW-101C infusion
Evaluate the Objective response rate (ORR) of NW-101C in patients with solid malignant tumors	Complete response (CR) and partial response (PR) assessed by investigators following RECIST1.1 criteria	2 years following NW-101C infusion
Evaluate the Cmax of NW-101C in patients with solid malignant tumors	Maximum Concentration(Cmax) assessed centrally	Through the study completion, an average of 2 years
Evaluate the Tmax of NW-101C in patients with solid malignant tumors	Time of Maximum Concentration assessed centrally	Through the study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Neowise Biotechnology

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NW-101C-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No