Tumor, SolidPhase 1NCT06956261
NW-301 TCR-T in Patients With Advanced Solid Tumor
A Phase 1 study testing NW-301V and Drug: NW-301D in people with Tumor, Solid, run by Peking University at 2 sites in China.
Trial summary
An open label, two cohorts, multiple dose exploratory clinical study to independently evaluate the safety, efficacy, and pharmacokinetics of autologous anti-KRAS G12V/G12D mutation T-cell Receptor T cell in advanced solid tumor Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- NW-301V and Drug: NW-301D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesChina
- Study dates
- 10 May 2025to 31 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years, male or female; Subjects with pathologically confirmed Pancreatic Cancer and Colorectal Cancer and Lung Adenocarcinoma Cancer and have been failed to stand of care systemic treatment or have been untolerated to stand of care systemic treatment; HLA-A*11:01 positive Tumor tissue samples. sample was positive for KRAS G12V or G12D mutation; Estimated life expectancy > 12 weeks; According to the RECIST 1.1, there is at least one measurable tumor lesion； ECOG physical status score 0 ~ 1; Sufficient venous access for mononuclear cell collection (abbreviation: apheresis) Subjects should have adequate organ functions before screening and pre-treatment (at baseline).
- Female subjects of childbearing age must undergo a serum pregnancy test at screening and prior to preconditioning and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment. The methods that can be used are: bilateral tubal ligation / bilateral salpingectomy or bilateral tubal occlusion; or approved oral, injection or hormone-imparting contraceptive methods; or barrier contraceptive method: containing spermicidal foam / Gel/film/cream/suppository condom or occlusive cap (diaphragm or cervix/cap); Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy, for example, a condom containing a spermicidal foam/gel/film/paste/suppository, or use a contraceptive method for their spouse (see article 9 of the inclusion criteria). Moreover, all men are absolutely forbidden to donate sperm within 1 year after receiving the last study treatment infusion； Subject participates in this clinical trial and sign Informed Consent Form voluntarily.
Who cannot join
- Received the following therapy/treatment : Cytotoxic chemotherapy within 1 week prior to leukapheresis or lymphodepleting chemotherapy , Immune therapy (including monoclonal antibody therapy, checkpoint inhibitors) within 2 weeks prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy Corticosteroids within 2 weeks prior to leukapheresis and within 72 hrs prior to lymphodepleting chemotherapy Immunosuppressive drugs within 2 weeks prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy Tyrosine kinase inhibitor (TKI) (e.g. pazopanib) within 1 week prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy KRAS G12V mutation targetted therapy prior to leukapheresis and lymphodepleting chemotherapy in KRAS G12V mutation cohort KRAS G12D mutation targetted therapy prior to leukapheresis and lymphodepleting chemotherapy in KRAS G12D mutation cohort Anti-cancer Vaccine, Gene therapy using an integrating vector , Investigational treatment or interventional clinical trial prior to leukapheresis and lymphodepleting chemotherapy Major surgery prior to leukapheresis History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.
- History of autoimmune or immune mediated disease Symptomatic CNS metastases including leptomeningeal disease. Other prior malignancy that is not considered by the Investigator to be in complete remission Clinically significant cardiovascular disease Uncontrolled intercurrent illness Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus Pregnant or breastfeeding
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 GoBroad Hospital
Beijing, Beijing Municipality, 100000
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100000
About this study
Official title: Open-label, Single-arm, Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Autologous TCR-T Cell Therapy in Subjects With Advanced Solid Tumors
An open label, two cohorts, multiple dose exploratory clinical study to independently evaluate the safety, efficacy, and pharmacokinetics of autologous anti-KRAS G12V/G12D mutation T-cell Receptor T cell in advanced solid tumor
Read the detailed description
This study is an open, two cohorts single infusion, dose escalation/dose regimen finding study to independently assess the safety and pharmacokinetics of KRAS G12V/G12D mutation TCR-T cell therapies, and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with KRAS G12V/G12D mutation and failed to standard systemic treatment
- Conditions
- Tumor, Solid
- Being tested
- NW-301V, Drug: NW-301D
- Keywords
- TCR-T, KRAS, G12V, G12D
- 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 T cell targeting KRAS G12V mutation
Drug: NW-301DDrug
TCR-T T cell targeting KRAS G12D mutation
| Study group | Role | What they receive |
|---|---|---|
| Experimental : NW-301V | Experimental | NW-301V monotherapy in patients with Solid Tumors with KRAS G12V mutation Expe Receives: Drug: NW-301V |
| Experimental : NW-301D | Experimental | NW-301D monotherapy in patients with Solid Tumors with KRAS G12D mutation Receives: Drug: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start10 May 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956261
- Sponsor's protocol ID
- NW-301-001
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-arm, Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Autologous TCR-T Cell Therapy in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06956261
- Acronym / sponsor ID
- NW-301-001
- Conditions
- Tumor, Solid
- Keywords
- TCR-T, KRAS, G12V, G12D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 10 May 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 May 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.
An open label, two cohorts, multiple dose exploratory clinical study to independently evaluate the safety, efficacy, and pharmacokinetics of autologous anti-KRAS G12V/G12D mutation T-cell Receptor T cell in advanced solid tumor
Detailed description
This study is an open, two cohorts single infusion, dose escalation/dose regimen finding study to independently assess the safety and pharmacokinetics of KRAS G12V/G12D mutation TCR-T cell therapies, and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with KRAS G12V/G12D mutation and failed to standard systemic treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : NW-301V | Experimental | Drug: NW-301VNW-301V monotherapy in patients with Solid Tumors with KRAS G12V mutation Expe |
| Experimental : NW-301D | Experimental | Drug: Drug: NW-301DNW-301D monotherapy in patients with Solid Tumors with KRAS G12D mutation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 to 75 years, male or female; Subjects with pathologically confirmed Pancreatic Cancer and Colorectal Cancer and Lung Adenocarcinoma Cancer and have been failed to stand of care systemic treatment or have been untolerated to stand of care systemic treatment; HLA-A*11:01 positive Tumor tissue samples. sample was positive for KRAS G12V or G12D mutation; Estimated life expectancy > 12 weeks; According to the RECIST 1.1, there is at least one measurable tumor lesion； ECOG physical status score 0 ~ 1; Sufficient venous access for mononuclear cell collection (abbreviation: apheresis) Subjects should have adequate organ functions before screening and pre-treatment (at baseline).
- Female subjects of childbearing age must undergo a serum pregnancy test at screening and prior to preconditioning and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment. The methods that can be used are: bilateral tubal ligation / bilateral salpingectomy or bilateral tubal occlusion; or approved oral, injection or hormone-imparting contraceptive methods; or barrier contraceptive method: containing spermicidal foam / Gel/film/cream/suppository condom or occlusive cap (diaphragm or cervix/cap); Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy, for example, a condom containing a spermicidal foam/gel/film/paste/suppository, or use a contraceptive method for their spouse (see article 9 of the inclusion criteria). Moreover, all men are absolutely forbidden to donate sperm within 1 year after receiving the last study treatment infusion； Subject participates in this clinical trial and sign Informed Consent Form voluntarily.
Key exclusion criteria (2 listed)
- Received the following therapy/treatment : Cytotoxic chemotherapy within 1 week prior to leukapheresis or lymphodepleting chemotherapy , Immune therapy (including monoclonal antibody therapy, checkpoint inhibitors) within 2 weeks prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy Corticosteroids within 2 weeks prior to leukapheresis and within 72 hrs prior to lymphodepleting chemotherapy Immunosuppressive drugs within 2 weeks prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy Tyrosine kinase inhibitor (TKI) (e.g. pazopanib) within 1 week prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy KRAS G12V mutation targetted therapy prior to leukapheresis and lymphodepleting chemotherapy in KRAS G12V mutation cohort KRAS G12D mutation targetted therapy prior to leukapheresis and lymphodepleting chemotherapy in KRAS G12D mutation cohort Anti-cancer Vaccine, Gene therapy using an integrating vector , Investigational treatment or interventional clinical trial prior to leukapheresis and lymphodepleting chemotherapy Major surgery prior to leukapheresis History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.
- History of autoimmune or immune mediated disease Symptomatic CNS metastases including leptomeningeal disease. Other prior malignancy that is not considered by the Investigator to be in complete remission Clinically significant cardiovascular disease Uncontrolled intercurrent illness Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus Pregnant or breastfeeding
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 T cell targeting KRAS G12V mutation | Drug | Experimental : NW-301V |
| Drug: NW-301DTCR-T T cell targeting KRAS G12D mutation | Drug | Experimental : NW-301D |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 28 days of single infusion
safety
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 4 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Tumor, Solid
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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 Drug: NW-301D in people with Tumor, Solid, run by Peking University 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 2 inclusion and 2 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 4 May 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 Changsong Qi, Doctor (13811394004, xiwangpku@126.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 4 May 2025.