Solid Metastatic TumorPhase 1NCT07266298
TCR-engineered T Cells (NW-101C) in Patients With Solid Malignant Tumors
A Phase 1 study testing NW-101C in people with Solid Metastatic Tumor, run by Neowise Biotechnology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Metastatic Tumor
- What is being tested?
- NW-101C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Dec 2025to Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- ECOG performance status of 0-1
- At least one tumor lesion measurable according to RECIST 1.1
- (Additional protocol-defined Inclusion criteria may apply)
Who cannot join
- 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
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- Active infections with HIV, HBV, HCV, or syphilis
- Breastfeeding or pregnant
- (Additional protocol-defined Exclusion criteria may apply)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer hosptial
Beijing, Beijing Municipality
Lin Shen, Medical Doctor, 010-88121122, doctorshenlin@sina.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Metastatic Tumor
- Being tested
- NW-101C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NW-101CBiological
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
| Study group | Role | What they receive |
|---|---|---|
| NW-101C dose 1-4 | Experimental | Not described Receives: Biological: NW-101C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through the study completion, an average of 2 years
Secondary outcomes (4)
Evaluate the AUC of NW-101C in patients with solid malignant tumors
Area under the Plasma concentration versus time curve(AUC) assessed centrally
Measured: 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
Measured: 2 years following NW-101C infusion
Evaluate the Cmax of NW-101C in patients with solid malignant tumors
Maximum Concentration(Cmax) assessed centrally
Measured: 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
Measured: Through the study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Metastatic TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neowise Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266298
- Sponsor's protocol ID
- NW-101C-002
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07266298
- Acronym / sponsor ID
- NW-101C-002
- Conditions
- Solid Metastatic Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Neowise BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| NW-101C dose 1-4 | Experimental | Biological: NW-101C |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NW-101C4 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 | Biological | NW-101C dose 1-4 |
Primary outcome
Evaluate the Dose-limiting toxicities(DLTs) of NW-101C in patients with solid malignant tumors
Time frame: 28 days following NW-101C infusion
Type, frequency and severity of adverse events assessed by CTCAE5.0
Evaluate the Maximum Tolerated Dose (MTD) of NW-101C in patients with solid malignant tumors
Time frame: Through the study completion, an average of 2 years
Type, frequency and severity of adverse events assessed by CTCAE5.0
4 secondary outcomes
Evaluate the AUC of NW-101C in patients with solid malignant tumors
Time frame: 2 years following NW-101C infusion
Evaluate the Objective response rate (ORR) of NW-101C in patients with solid malignant tumors
Time frame: 2 years following NW-101C infusion
Evaluate the Cmax of NW-101C in patients with solid malignant tumors
Time frame: Through the study completion, an average of 2 years
Evaluate the Tmax of NW-101C in patients with solid malignant tumors
Time frame: Through the study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NW-101C in people with Solid Metastatic Tumor, run by Neowise Biotechnology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuhui He (0512-67991566, yuhui.he@neowisebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Dose-limiting toxicities(DLTs) of NW-101C in patients with solid malignant tumors (time frame: 28 days following NW-101C infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.