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
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