TCR-engineered T Cells (NW-101C) in Patients With Solid Malignant Tumors
NCT ID: NCT07266298
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2025-12-31
2030-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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NW-101C dose 1-4
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Neowise Biotechnology
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer hosptial
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NW-101C-002
Identifier Type: -
Identifier Source: org_study_id
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