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KRAS G12VEarly Phase 1NCT07342738

TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors

A Early Phase 1 study testing TCR-T cells, Fludarabine and Cyclophosphamide in people with KRAS G12V and KRAS G12D, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-arm, Multicenter, open-label clinical study aimed at evaluating the safety and efficacy of TCR-T injection in patients with advanced solid tumors induced by KRAS mutations. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
KRAS G12V, KRAS G12D, Solid Tumor
What is being tested?
TCR-T cells, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
1 Feb 2026to 1 Feb 2029
Phase
Early 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

  • Voluntary signing of an informed consent form (ICF)；
  • Males or females, aged 18-70 years (inclusive);
  • Subjects with advanced solid tumors confirmed by histology/cytology, have failed with standard treatment, or intolerant to standard treatment, or no standard treatment exists：1）Colorectal cancer：failed or intolerant to at least two lines of standard treatment.2）Non-small cell lung cancer：Absence of the following gene mutations (Epidermal Growth Factor Receptor[EGFR]、Anaplastic Lymphoma Kinase[ALK] 、 Proto-oncogene tyrosine-protein kinase 1[ROS1]) and having failed or intolerant to platinum-based chemotherapy and/or immunotherapy and/or anti-angiogenic therapy.3）Other advanced solid tumors：failed with standard treatment, or intolerant to standard treatment, or no standard treatment exist.
  • At least one measurable lesion (according to Response Evaluation Criteria in Solid Tumors[RECIST], version 1.1);
  • Patients with tumor tissue or peripheral blood testing positive for KRAS-G12V or G12D mutations and expression of matching HLA-A*11:01 or HLA-C*01:02 subtypes;
  • ECOG (Eastern Cooperative Oncology Group)≤2;
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  • Life expectancy ≥3 months;
  • Adequate functional reserve of organs：1）Hematology (no intensive blood transfusion, platelet transfusion or cell growth factor performed within 14 days before the test)：·Absolute neutrophil count ≥1×10E9/L;·Platelet count ≥50×10E9/L, hemoglobin>90g/L;·Absolute lymphocyte count ≥0.5×10E9/L;2）Blood chemistry：·Alanine aminotransferase (ALT) ≤3×Upper Limit of Normal (ULN);·Aspartate aminotransferase (AST) ≤3×ULN（patients with hepatic metastasis, ALT and AST ≤5×ULN）;·Serum creatinine ≤1.5×ULN or Creatinine clearance ≥50 mL/min;·Total bilirubin (TB) ≤1.5×ULN；3）Blood chemistry：·APTT≤1.5×ULN，INR≤1.5×ULN4）The subject has left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant pericardial effusion diagnosed by echocardiography;5）No clinically significant electrocardiographic abnormality;6）Basic oxygen saturation is >92% under the indoor natural air environment.
  • Women of childbearing age must be negative for blood HCG (Human Chorionic Gonadotropin) pregnancy test (by immunofluorescence method) at screening and baseline periods, and agree to use effective contraception for at least 1 year after infusion; and male subjects whose partners are women of childbearing age must agree to use effective barrier contraception methods and avoid sperm donation for at least 1 year after infusion.

Who cannot join

  • Other malignancies (except non-melanoma skin cancer with the disease-free survival of more than 5 years and cervical carcinoma in situ, bladder cancer, or breast cancer);
  • History of organ transplantation；
  • A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the ICF;
  • A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis and systemic lupus erythematosus) requiring systemic immunosuppressive/systemic disease-modulating drugs；
  • Poorly controlled hypertension with drug (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg) or occurrence of grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stent placement, unstable angina pectoris, or other clinically significant heart diseases within one year prior to signing the ICF; Corrected QT Interval (QTc) interval >450 ms for males or QTc interval >470 ms for females during screening (QTc interval calculated using the Fridericia formula)；
  • Patients with intestinal obstruction or obstructive jaundice and are deemed ineligible for enrollment by the investigator；
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  • Symptomatic intracranial metastases, or moderate to severe ascites or pleural effusion requiring drainage to relieve symptoms；
  • A history of or any central nervous system disorders, such as epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system within the past 6 months；
  • A positive result obtained in any of the following virological tests:1）Antibody to human immunodeficiency virus (HIV antibody); 2）Hepatitis C virus antibody (HCV antibody), with a positive result for hepatitis C virus ribonucleic acid (HCV RNA); 3）Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) copies ≥2000 IU/mL; 4）Treponema pallidum antibody (TP antibody) and positive for unheated serum reagin test;
  • Fungal, bacterial, viral or other infections or suspected fungal, bacterial, viral or other infections that cannot be controlled or require intravenous administration；
  • Significant tendency for bleeding, such as active gastrointestinal bleeding, coagulation disorders；
  • Deep vein thrombosis requiring treatment within the past 6 months, unless the risk of thrombosis is acceptable after treatment, as assessed by the investigator；
  • Interstitial lung disease (such as interstitial pneumonia, pulmonary fibrosis), or a history of clinically significant respiratory system diseases at screening；
  • Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to leukapheresis；
  • Participation in any other clinical studies within 1 month prior to signing the master informed consent form；
  • Patients with poor compliance due to physiological, family, social, geographic and other factors, and failure to follow the study protocol and the follow-up plan；
  • Patients with contraindications to drugs used in the study；
  • Comorbidities requiring treatment with systemic corticosteroids (dexamethasone at a dose of ≥ 5 mg/day or other corticosteroids at the equivalent dose) or other immunosuppressive drugs after initiation of the study treatment, as judged by the investigator；
  • Women who are breastfeeding and are unwilling to stop breastfeeding；
  • Any other conditions that are, in the opinion of the investigator, not suitable for enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yu-hong Li, MD, Ph D contact

87342487 ext. 020

liyh@sysucc.org.cn

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Cliniacl Study of T Cell Receptor-engineered T-Cell (TCR-T) Injection in Patients With Advanced Solid Tumors Induced by Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations.

This is a single-arm, Multicenter, open-label clinical study aimed at evaluating the safety and efficacy of TCR-T injection in patients with advanced solid tumors induced by KRAS mutations.

Read the detailed description

This study is planned to enroll patients with advanced solid tumors who have KRAS G12V or G12D mutations and matching Human Leukocyte Antigen(HLA)-A*11:01 or HLA-C*01:02 subtypes. The study consists of screening period, leukapheresis period, lymphodepletion period, treatment period, observation period and follow-up period. The patients were treated lymphodepletion treatment with cyclophosphamide and fludarabine and than infused TCR-T. All subjects who have received TCR-T injection will be followed for safety and efficacy up to 1 years.

Being tested
TCR-T cells, Fludarabine, Cyclophosphamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TCR-T cellsBiological

    TCR-T cell injection will be administered intravenously after lymphodepletion.

  • FludarabineDrug

    Fludarabine is used for lymphodepletion.

  • CyclophosphamideDrug

    Cyclophosphamide is used for lymphodepletion.

Study groups in NCT07342738
Study groupRoleWhat they receive
TCR-T cellsExperimentalTCR-T cells targeted for KRAS mutation
Receives: Biological: TCR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events (AEs)

    Incidence and severity of adverse events

    Measured: 1 year

  2. Serious Adverse Events (SAEs)

    Incidence and severity of serious adverse events

    Measured: 1 year

Secondary outcomes (9)

  1. Objective Response Rate (ORR)

    The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1

    Measured: 1 year

  2. Disease Control Rate (DCR)

    The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1

    Measured: 1 year

  3. Duration of response (DOR)

    DOR is defined as the time from the first evaluation of a tumor as CR or PR to the first evaluation as progressive disease (PD) or death from any cause

    Measured: 1 year

  4. Time to response (TTR)

    TTR is defined as the time between cell infusion and initial disease assessment as CR or PR

    Measured: 1 year

  5. Progression-free survival (PFS)

    PFS is defined as the time from the date of cell infusion until the date of tumor progression or death from any cause

    Measured: 1 year

  6. Overall survival (OS)

    OS is defined as the time between the date of cell infusion and the death of the patient for any reason

    Measured: 1 year

  7. Cmax of TCR-T cells after infusion

    Peak peripheral blood concentration of TCR-T cells following infusion, measured by flow cytometry.

    Measured: 1 year

  8. Tmax of TCR-T cells after infusion

    Time to reach maximum observed concentration (Tmax) of TCR-T cells

    Measured: 1 year

  9. Peak level of cytokines in serum after infusion

    The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, tumor necrosis factor-α (TNF-α), C reactive protein (CRP),Interferon gamma (IFN-γ) .Peak was defined as the maximum post-baseline level of the cytokine.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07342738
Sponsor's protocol ID
BT004 TCR-T
Status last verified
Jan 2026
First submitted
5 Jan 2026
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing TCR-T cells, Fludarabine and Cyclophosphamide in people with KRAS G12V and KRAS G12D, run by Sun Yat-sen University 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 20 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 Jan 2026. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Yu-hong Li, MD, Ph D (87342487 ext. 020, liyh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: 1 year). 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?

On the ClinicalTrials.gov record for NCT07342738.

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 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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