Advanced Solid CancerPhase 1NCT07875920
Phase 1 Study of NW-301V TCR-T Cells in Advanced Solid Tumors With KRAS G12V Mutation
A Phase 1 study testing Fludarabine, Cyclophosphamide and NW-301V in people with Advanced Solid Cancer and Pancreatic Ductal Adenocarcinoma (PDAC), run by Neowise Biotechnology at 2 sites in China.
Trial summary
This is a single-arm, multicenter, open-label, Phase 1a/1b dose-escalation and dose-expansion study designed to evaluate the safety, preliminary antitumor activity, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of NW-301V, an autologous TCR-T cell therapy, in Chinese adult participants with advanced… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Cancer, Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Adenocarcinoma
- What is being tested?
- Fludarabine, Cyclophosphamide and NW-301V
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2026to Mar 2033
- 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
- Applicable to both Phase 1a and 1b:
- Age between 18-75 years
- HLA-A*11:01 positive
- Tumor confirmed to have KRAS G12V mutation
- At least one measurable lesion according to RECIST 1.1
- ECOG 0-1
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- Life expectancy > 3 months before leukapheresis
- Adequate organ functions prior to leukapheresis and lymphodepletion
- For Phase 1a only:
- Histologically or pathologically confirmed, advanced or unresectable solid tumors including, but not limited to, pancreatic ductal adenocarcinoma (PDAC), colorectal adenocarcinoma (CRC), and lung adenocarcinoma (LUAD)
- Participants must have no standard treatment options available or are unable to tolerate currently available standard treatment
- For Phase 1b only:
- Cohort A: Histologically or pathologically confirmed advanced or locally advanced unresectable PDAC that had failed or progressed after at least 1 line of prior systemic therapy
- Cohort B: Histologically or pathologically confirmed advanced CRC that had failed or progressed after at least 2 lines of prior systemic therapies
- Cohort C: Histologically or pathologically confirmed advanced LUAD that had failed or progressed after at least 1 line of prior systemic therapy
- (Additional protocol-defined Inclusion criteria may apply)
Who cannot join
- Applicable to both Phase 1a and 1b:
- Received the following treatments: Cytotoxic chemotherapy or immunosuppressive agents within 2 weeks prior to leukapheresis, or within 1 week prior to lymphodepletion; Antibodies or other biologic therapy within 3 weeks prior to leukapheresis, or within 2 weeks 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 leukapheresis or lymphodepletion
- Have symptomatic CNS metastases
- Have leptomeningeal disease or carcinomatous meningitis
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- Have ongoing or active infection
- Breastfeeding or pregnant
- (Additional protocol-defined Inclusion 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
Beijing Cancer Hosptial
Beijing, Beijing Municipality
Lin Shen, MD, +86-10-88121122, doctorshenlin@sina.com
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Tingbo Liang, MD, PhD, +86-571-87236114, liangtingbo@zju.edu.cn
About this study
Official title: A Single-Arm, Multicenter, Open-Label, Phase Ia/Ib Clinical Study of NW-301V in Advanced Solid Tumors Harboring KRAS G12V Mutations
This is a single-arm, multicenter, open-label, Phase 1a/1b dose-escalation and dose-expansion study designed to evaluate the safety, preliminary antitumor activity, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of NW-301V, an autologous TCR-T cell therapy, in Chinese adult participants with advanced malignant solid tumors harboring a KRAS G12V mutation.
Read the detailed description
There are 2 parts in this study：
- Phase 1a: Dose Escalation. A conventional 3+3 dose escalation design will be used to assess the safety/tolerability, pharmacokinetics (PK) and preliminary antitumor activity of NW-301V in participants with advanced or locally unresectable solid tumors who meet the enrollment criteria. A provisional Recommended Phase 2 Dose (RP2D) of NW-301V will be determined.
- Phase 1b: Dose expansion. Participants with pancreatic ductal adenocarcinoma (PDAC), colorectal adenocarcinoma (CRC) or lung adenocarcinoma (LUAD) who meet the eligibility criteria will be enrolled into three separate disease-specific cohorts. The final RP2D will be determined.
Participants who meet the protocol-defined eligibility criteria during screening will undergo leukapheresis for the manufacture of NW-301V. Prior to NW-301V infusion, participants will receive a lymphodepletion (LD) regimen consisting of fludarabine and cyclophosphamide. Participants will be closely monitored for safety, tolerability and treatment response throughout the study.
- Conditions
- Advanced Solid Cancer, Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Adenocarcinoma, Lung Adenocarcinoma, KRAS G12V, Pancreatic Cancer
- Being tested
- Fludarabine, Cyclophosphamide, NW-301V
- Keywords
- TCR-T, TCR-T cell therapy, PDAC, CRC, LUAD, Pancreatic cancer, Colorectal cancer, NSCLC, KRAS, KRAS G12V, HLA-A*11:01, Solid tumors
- Medical subject headings
- Adenocarcinoma of Lung, Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Used for lymphodepletion
CyclophosphamideDrug
Used for lymphodepletion
NW-301VBiological
NW-301V is an autologous TCR-T cell therapy targeting KRAS G12V in the context of HLA-A*11:01, administered intravenously after lymphodepletion.
| Study group | Role | What they receive |
|---|---|---|
| NW-301V | Experimental | Participants receive lymphodepletion and a single infusion of NW-301V, an autologous TCR-T cell therapy targeting KRAS G12V. In Phase 1a (dose escalation), two dose levels at 4×10^9 (±30%) and 8×10^9 (±30%) TCR-T+ cells will be tested. In Phase 1b (dose expansion), NW-301V will be administered at provisional RP2D in 3 tumor-specific cohorts (Cohort A: pancreatic ductal adenocarcinoma; Cohort B: colorectal adenocarcinoma; Cohort C: lung adenocarcinoma), each containing around 20 participants. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: NW-301V |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Safety and tolerability of NW-301V in participants with advanced solid tumors
Type, frequency, and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), abnormalities in vital signs, electrocardiograms (ECGs) and other laboratory results.
Measured: Through the study completion, an average of 2 years
Phase 1a: Maximum tolerated dose (MTD, if applicable) and provisional Recommended Phase 2 Dose (RP2D)
Number of participants with dose-limiting toxicities (DLTs) and their types.
Measured: 28 days
Phase 1b: Safety and tolerability of NW-301V in PDAC, CRC and LUAD respectively under provisional RP2D
Type, frequency, and severity of TEAEs, SAEs, and abnormalities in vital signs, ECGs and other laboratory results.
Measured: Through the study completion, an average of 2 years
Phase 1b: Final RP2D of NW-301V
Determine the final RP2D of NW-301V
Measured: Up to 2 years
Secondary outcomes (8)
Objective response rate (ORR)
Assessed by RECIST v1.1. (Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)
Measured: Through the study completion, an average of 2 years
Disease control rate (DCR)
Assessed by RECIST v1.1. (Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)
Measured: Through the study completion, an average of 2 years
Duration of response (DOR)
Assessed by RECIST v1.1. (Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)
Measured: Through the study completion, an average of 2 years
Progression-free survival (PFS)
Assessed by RECIST v1.1. (Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)
Measured: Through the study completion, an average of 2 years
Overall survival (OS)
(Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)
Measured: Through the study completion, an average of 2 years
Maximum blood concentration (Cmax) of NW-301V
Measured: Through the study completion, an average of 2 years
Time to maximum concentration (Tmax) of NW-301V
Measured: Through the study completion, an average of 2 years
Persistence of NW-301V TCR-T cells in vivo
Determined by qPCR-measured gene copies
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 posted15 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT07875920
- Sponsor's protocol ID
- NW-301V-001
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Open-Label, Phase Ia/Ib Clinical Study of NW-301V in Advanced Solid Tumors Harboring KRAS G12V Mutations
- ClinicalTrials.gov ID
- NCT07875920
- Acronym / sponsor ID
- NW-301V-001
- Conditions
- Advanced Solid Cancer, Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Adenocarcinoma, Lung Adenocarcinoma, KRAS G12V, Pancreatic Cancer
- Keywords
- TCR-T, TCR-T cell therapy, PDAC, CRC, LUAD, Pancreatic cancer, Colorectal cancer, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Neowise BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 15 Oct 2026 (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 is a single-arm, multicenter, open-label, Phase 1a/1b dose-escalation and dose-expansion study designed to evaluate the safety, preliminary antitumor activity, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of NW-301V, an autologous TCR-T cell therapy, in Chinese adult participants with advanced malignant solid tumors harboring a KRAS G12V mutation.
Detailed description
There are 2 parts in this study：
- Phase 1a: Dose Escalation. A conventional 3+3 dose escalation design will be used to assess the safety/tolerability, pharmacokinetics (PK) and preliminary antitumor activity of NW-301V in participants with advanced or locally unresectable solid tumors who meet the enrollment criteria. A provisional Recommended Phase 2 Dose (RP2D) of NW-301V will be determined.
- Phase 1b: Dose expansion. Participants with pancreatic ductal adenocarcinoma (PDAC), colorectal adenocarcinoma (CRC) or lung adenocarcinoma (LUAD) who meet the eligibility criteria will be enrolled into three separate disease-specific cohorts. The final RP2D will be determined.
Participants who meet the protocol-defined eligibility criteria during screening will undergo leukapheresis for the manufacture of NW-301V. Prior to NW-301V infusion, participants will receive a lymphodepletion (LD) regimen consisting of fludarabine and cyclophosphamide. Participants will be closely monitored for safety, tolerability and treatment response throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NW-301V | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: NW-301VParticipants receive lymphodepletion and a single infusion of NW-301V, an autologous TCR-T cell therapy targeting KRAS G12V. In Phase 1a (dose escalation), two dose levels at 4×10^9 (±30%) and 8×10^9 (±30%) TCR-T+ cells will be tested. In Phase 1b (dose expansion), NW-301V will be administered at provisional RP2D in 3 tumor-specific cohorts (Cohort A: pancreatic ductal adenocarcinoma; Cohort B: colorectal adenocarcinoma; Cohort C: lung adenocarcinoma), each containing around 20 participants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age between 18-75 years
- HLA-A*11:01 positive
- Tumor confirmed to have KRAS G12V mutation
- At least one measurable lesion according to RECIST 1.1
- ECOG 0-1
Key exclusion criteria (9 listed)
- Received the following treatments: Cytotoxic chemotherapy or immunosuppressive agents within 2 weeks prior to leukapheresis, or within 1 week prior to lymphodepletion; Antibodies or other biologic therapy within 3 weeks prior to leukapheresis, or within 2 weeks 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 leukapheresis or lymphodepletion
- Have symptomatic 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 |
|---|---|---|
| FludarabineUsed for lymphodepletion | Drug | NW-301V |
| CyclophosphamideUsed for lymphodepletion | Drug | NW-301V |
| NW-301VNW-301V is an autologous TCR-T cell therapy targeting KRAS G12V in the context of HLA-A*11:01, administered intravenously after lymphodepletion. | Biological | NW-301V |
Primary outcome
Phase 1a: Safety and tolerability of NW-301V in participants with advanced solid tumors
Time frame: Through the study completion, an average of 2 years
Type, frequency, and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), abnormalities in vital signs, electrocardiograms (ECGs) and other laboratory results.
Phase 1a: Maximum tolerated dose (MTD, if applicable) and provisional Recommended Phase 2 Dose (RP2D)
Time frame: 28 days
Number of participants with dose-limiting toxicities (DLTs) and their types.
Phase 1b: Safety and tolerability of NW-301V in PDAC, CRC and LUAD respectively under provisional RP2D
Time frame: Through the study completion, an average of 2 years
Type, frequency, and severity of TEAEs, SAEs, and abnormalities in vital signs, ECGs and other laboratory results.
Phase 1b: Final RP2D of NW-301V
Time frame: Up to 2 years
Determine the final RP2D of NW-301V
8 secondary outcomes
Objective response rate (ORR)
Time frame: Through the study completion, an average of 2 years
Disease control rate (DCR)
Time frame: Through the study completion, an average of 2 years
Duration of response (DOR)
Time frame: Through the study completion, an average of 2 years
Progression-free survival (PFS)
Time frame: Through the study completion, an average of 2 years
Overall survival (OS)
Time frame: Through the study completion, an average of 2 years
Maximum blood concentration (Cmax) of NW-301V
Time frame: Through the study completion, an average of 2 years
Time to maximum concentration (Tmax) of NW-301V
Time frame: Through the study completion, an average of 2 years
Persistence of NW-301V TCR-T cells in vivo
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 15 Oct 2026.
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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 Fludarabine, Cyclophosphamide and NW-301V in people with Advanced Solid Cancer and Pancreatic Ductal Adenocarcinoma (PDAC), run by Neowise Biotechnology 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 16 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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, Master Degree (+86-512-67991566, rui.liu@neowisebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Safety and tolerability of NW-301V in participants with advanced solid tumors (time frame: Through the study completion, an average of 2 years). The study lists 4 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 15 Oct 2026.