Tumor, SolidPhase 1NCT06484556
T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
A Phase 1 study testing NW-301V and NW-301D in people with Tumor, Solid, run by Tao Zhang at 2 sites in China.
Trial summary
An open label, two-cohort, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics/pharmacodynamic (PK/PD) of NW-301V and NW-301D in subjects with advanced solid tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- NW-301V and NW-301D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesChina
- Study dates
- 19 Jun 2024to 30 Jun 2027
- 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 tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments
- HLA-A*11:01positive
- Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation
- 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.)
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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
ZhenYu Lin
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei
Tao Zhang, MD, PHD, 862785871982, 1277577866@qq.com
Zhenyu Lin, MD, 15827130393, tojilin@gmail.com
About this study
Official title: An Open-Label, Dose-Escalation Phase I Clinical Study of T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
An open label, two-cohort, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics/pharmacodynamic (PK/PD) of NW-301V and NW-301D in subjects with advanced solid tumor.
Read the detailed description
Using a modified 3+3 dose escalation design, this study will enroll ~9 subjects to characterize the safety and preliminary anti-tumor activity of NW-301V and NW-301D in each cohort respectively. Eligible subjects will undergo leukapheresis for autologous cell product manufacturing, and will receive a 3-day lymphodepleting regimen consisting of cyclophosphamide and fludarabine, followed by a single-dose intravenous infusion of NW-301V or NW-301D. after NW-301V or NW-301D infusion, a low dose of IL-2 will be given subcutaneously for up to 10 days. following this intervention, subjects will be monitored for safety and AE, and tumor evaluation will be performed at pre-specified timepoints per protocol.
- Conditions
- Tumor, Solid
- Being tested
- NW-301V, NW-301D
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NW-301VDrug
TCR-T cell targeting KRAS G12V mutation
NW-301DDrug
TCR-T cell targeting KRAS G12D mutation
| Study group | Role | What they receive |
|---|---|---|
| NW-301V | Experimental | NW-301V monotherapy in patients with Solid Tumors with KRAS G12V mutation Receives: Drug: NW-301V |
| NW-301D | Experimental | NW-301D monotherapy in patients with Solid Tumors with KRAS G12D mutation Receives: Drug: NW-301D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Safety
Measured: 28 days of single infusion
Secondary outcomes (2)
Objective response rate (ORR)
Complete response (CR) and partial response (PR) based on best overall response (BOR), locally assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: through the completion of the study, with average of 2 years
Duration of response (DOR)
CR and PR, locally assessed using RECIST v1.1
Measured: through the completion of the study, with 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 posted3 Jul 2024
- Study start19 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Neowise Biotechnology
- Responsible party
- Sponsor-investigator, Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484556
- Sponsor's protocol ID
- NW-301-001
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not provided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalation Phase I Clinical Study of T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT06484556
- Acronym / sponsor ID
- NW-301-001
- Conditions
- Tumor, Solid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Tao ZhangUniversity, hospital or other
- Collaborators
- Neowise Biotechnology
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Jul 2024 (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.
An open label, two-cohort, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics/pharmacodynamic (PK/PD) of NW-301V and NW-301D in subjects with advanced solid tumor.
Detailed description
Using a modified 3+3 dose escalation design, this study will enroll ~9 subjects to characterize the safety and preliminary anti-tumor activity of NW-301V and NW-301D in each cohort respectively. Eligible subjects will undergo leukapheresis for autologous cell product manufacturing, and will receive a 3-day lymphodepleting regimen consisting of cyclophosphamide and fludarabine, followed by a single-dose intravenous infusion of NW-301V or NW-301D. after NW-301V or NW-301D infusion, a low dose of IL-2 will be given subcutaneously for up to 10 days. following this intervention, subjects will be monitored for safety and AE, and tumor evaluation will be performed at pre-specified timepoints per protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NW-301V | Experimental | Drug: NW-301VNW-301V monotherapy in patients with Solid Tumors with KRAS G12V mutation |
| NW-301D | Experimental | Drug: NW-301DNW-301D monotherapy in patients with Solid Tumors with KRAS G12D mutation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18-75 years
- Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments
- HLA-A*11:01positive
- Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation
- Adequate organ function prior to apheresis and lymphodepleting chemotherapy
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-301VTCR-T cell targeting KRAS G12V mutation | Drug | NW-301V |
| NW-301DTCR-T cell targeting KRAS G12D mutation | Drug | NW-301D |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 28 days of single infusion
Safety
2 secondary outcomes
Objective response rate (ORR)
Time frame: through the completion of the study, with average of 2 years
Duration of response (DOR)
Time frame: through the completion of the study, with 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 31 Jul 2025.
- Individual participant dataSharing planned: No. Not provided
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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.
2 sites 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-301V and NW-301D in people with Tumor, Solid, run by Tao Zhang at 2 sites 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 8 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 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Rui Liu (15377559472, rui.liu@neowisebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 28 days of single infusion). 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 31 Jul 2025.