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Advanced Solid TumorsPhase 1NCT07207681

Personalized KXV01 TCR Lentinvivo Injection as the Therapy for Advanced Solid Tumors

A Phase 1 study testing KXV01 TCR Lentinvivo Injection in people with Advanced Solid Tumors, run by The First Hospital of Jilin 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
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Trial summary

This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KXV01 TCR Lentinvivo for patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
KXV01 TCR Lentinvivo Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
15 Oct 2025to 31 Dec 2028
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

  • Voluntarily participate in the clinical study; fully understand the study and voluntarily sign the informed consent form; be willing to comply with and able to complete all trial procedures.
  • Aged 18 to 70 years (inclusive).
  • Histologically or cytologically confirmed incurable or metastatic solid tumors that have failed standard treatment, or for which no standard treatment is currently available.
  • Expected survival time > 6 months.
  • ECOG performance status of 0 or 1.
  • Sufficient organ function, defined as follows:
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  • 6.1) Hematological system: 6.1.1) Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days prior to the test); 6.1.2) Absolute neutrophil count ≥ 1.5 × 10⁹/L (no granulocyte colony-stimulating factor treatment within 14 days prior to the test); 6.1.3) Platelet count ≥ 100 × 10⁹/L in the absence of significant hepatic lesions (primary or metastatic) (no platelet transfusion within 14 days prior to the test), or ≥ 75 × 10⁹/L in the presence of hepatic lesions (no platelet transfusion within 14 days prior to the test); 6.1.4) Absolute lymphocyte count (ALC) ≥ 0.7 × 10⁹/L; 6.2) Hepatic function: 6.2.1) Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) in the absence of significant hepatic lesions (primary or metastatic), and ≤ 3 × ULN in subjects with hepatic lesions or Gilbert's disease; 6.2.2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in subjects with liver metastasis or liver cancer); alkaline phosphatase (ALP) ≤ 2.5 × ULN (≤ 5 × ULN in subjects with bone metastasis); 6.3) Renal function: Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula: ([140 - age] × weight [kg] × [0.85, for females only]) / (72 × creatinine (mg/dl))); 6.4) Baseline oxygen saturation > 92% during natural breathing (without auxiliary oxygen supply).
  • Patients whose tumor lesions can be collected and from whom tumor-reactive TCR sequences can be identified may enter the study. If a patient has obtained individualized TCR sequences from previously collected archived tumor tissue in other studies, they may directly enter Screening Period 2, provided that the archived tissue was collected within one year prior to signing the informed consent form for this study.
  • Women of childbearing age must have a negative urine/blood pregnancy test during the screening period and agree to use contraceptive measures for at least 1 year after administration; male subjects whose partners are of childbearing potential must agree to use effective barrier contraception for at least 1 year after administration.
  • The patient's organ function and key test items at this stage should not have significant changes compared with their test results in Screening Period 1. If the patient's test results in Screening Period 2 exceed the following criteria, they should not receive administration of KXV01 Injection until the abnormal items return to the normal range.
  • The patient's KXV01 Injection has been successfully prepared.
  • Expected survival time > 6 months.
  • ECOG performance status of 0 or 1.
  • Sufficient organ function.
  • Females of childbearing potential have a negative blood pregnancy test within 7 days prior to administration of the study drug (Non-childbearing potential: surgically sterilized or postmenopausal for at least 2 years). In addition, female subjects of childbearing potential must use medically approved contraceptive measures for 12 months after the start of study treatment and have no egg retrieval during this period.
  • Male subjects are willing to use medically approved contraceptive measures from the time of signing the informed consent form until 12 months after the start of study treatment, and will not donate sperm during this period.
  • At least one measurable lesion according to RECIST v1.1 criteria.
  • Toxicities and adverse reactions caused by prior therapy should have resolved to Grade ≤ 1 (except for toxicities considered clinically insignificant, such as chemotherapy-induced alopecia).

Who cannot join

  • A history of other malignant tumors within 2 years prior to signing the informed consent form, except for non-melanoma skin cancer, some in situ carcinomas (e.g., cervical cancer, bladder cancer, breast cancer), or low-risk prostate cancer.
  • Uncontrolled infectious diseases within 4 weeks prior to signing the informed consent form.
  • Active hepatitis B or hepatitis C virus infection.
  • Patients with HIV infection.
  • Patients with positive Treponema pallidum.
  • A history of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, coronary angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases.
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  • Tumor lesions invading the heart or major blood vessels.
  • Abnormal pulmonary function indicated by a ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) < 70% in pulmonary function tests.
  • A history of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disease, and organic brain syndrome.
  • Use of the following drugs or treatments:
  • Hormones: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent > 20 mg/day) within 72 hours prior to administration of the study drug; physiologic replacement doses, topical, and inhaled steroids are permitted;
  • Chemotherapy: Receipt of salvage chemotherapy within 2 weeks prior to administration of the study drug;
  • GvHD treatment: Receipt of anti-GvHD therapy within 4 weeks prior to administration of the study drug;
  • Allogeneic bone marrow transplantation;
  • Gene therapy;
  • Adoptive cell therapy;
  • Females who are pregnant or breastfeeding.
  • A history of primary immunodeficiency or autoimmune disease, except for the following:
  • History of hypothyroidism with stable thyroid hormone replacement therapy;
  • Patients with well-controlled type 1 diabetes mellitus.
  • Patients whose disease or condition renders them unable to understand, participate in, and/or comply with the study protocol.
  • Any other disease that the investigator believes would impair the subject's ability to tolerate protocol treatment or significantly increase the risk of complications.
  • Current or past history of psychoactive substance abuse or dependence.
  • Subjects whose underlying condition, in the investigator's judgment, may increase the risk of receiving the investigational drug or confound the interpretation of toxic reactions and adverse events.
  • Other conditions deemed unsuitable for participation in the study by the investigator.
  • Screening Period 2
  • Prior to administration of the study drug, the subject's anti-tumor therapy has not been sufficiently washed out (2 weeks or 5 half-lives, whichever is shorter):
  • Except for the following:
  • Gonadotropin (GnRH) agonists or antagonists used for the treatment of prostate cancer
  • Hormone replacement therapy, or oral contraceptives.
  • Uncontrolled infectious diseases within the previous 4 weeks.
  • Active hepatitis B or hepatitis C virus infection.
  • Patients with HIV infection.
  • Patients with positive Treponema pallidum.
  • Tumor lesions invading the heart or major blood vessels.
  • A history of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disease, and organic brain syndrome.
  • Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases.
  • Use of the following drugs or treatments between Screening Period 1 and Screening Period 2:
  • Hormones: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent > 20 mg/day) within 72 hours prior to administration of the study drug; physiologic replacement doses, topical, and inhaled steroids are permitted;
  • Chemotherapy: Receipt of salvage chemotherapy within 2 weeks prior to administration of the study drug;
  • GvHD treatment: Receipt of anti-GvHD therapy within 4 weeks prior to administration of the study drug;
  • Allogeneic bone marrow transplantation;
  • Gene therapy;
  • Adoptive cell therapy;
  • Use of alemtuzumab within 6 months prior to administration of the study drug, or clofarabine or cladribine within 3 months prior to administration;
  • Receipt of radiotherapy between Screening Period 1 and Screening Period 2. Patients are eligible only if lesions within the radiation field show progressive disease (PD), or there are measurable lesions outside the radiation field meeting RECIST v1.1 criteria on imaging assessment; if there are measurable lesions outside the radiation field, radiotherapy to other lesions must be at least 2 weeks apart from the administration date of the study drug.
  • Females who are pregnant or breastfeeding.
  • Subjects whose underlying condition, in the investigator's judgment, may increase the risk of receiving the investigational drug or confound the interpretation of toxic reactions and adverse events.
  • Receipt of major surgery (excluding diagnostic surgery) between Screening Period 1 and Screening Period 2, or expected to undergo major surgery during the study period. Subjects with planned or ongoing minor surgical procedures (such as venous access placement, etc.) are eligible 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.

Jiuwei Cui contact

043188783173

chennaifei@jlu.edu.cn

China1 site

  • First Hospital of Jilin University

    Changchun, Jilin, 130013

    Principle Investigator, 043188783173, chennaifei@jlu.edu.cn

    Jiuwei Cui

Other trials in China

About this study

Official title: A Phase I Clinical Study of KXV01 TCR Lentinvivo Injection on Safety, Tolerability, and Efficacy in Patients With Advanced Solid Tumors

This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KXV01 TCR Lentinvivo for patients with advanced solid tumors.

Read the detailed description

In recent years, the field has found that patient-specific anti-tumor treatment technologies have increasingly significant clinical application prospects and clinical value. Patient-specific anti-tumor in vivo TCR gene therapy is an advanced therapeutic strategy that can specifically recognize tumor neoantigens. This strategy is not restricted by patients' HLA typing nor by the type of indication.

This investigator-initiated clinical study aims to evaluate KXV01 TCR Lentinvivo, the third-generation self-inactivating lentiviral vector that carries patient-derived personalized tumor reactive TCR, in patients with advanced solid tumors. The study employs a BOIN design to assess safety, tolerability, and preliminary efficacy.

Being tested
KXV01 TCR Lentinvivo Injection

What participants receive

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

  • KXV01 TCR Lentinvivo InjectionDrug

    KXV01 TCR Lentinvivo Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries an effective patient's personalized tumor-reactive TCR.

Study groups in NCT07207681
Study groupRoleWhat they receive
KXV01 TCR Lentinvivo InjectionExperimentalKXV01 TCR Lentinvivo Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries patient's personalized tumor-reactive TCR.
Receives: Drug: KXV01 TCR Lentinvivo Injection

What is being measured

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

  1. Dose-limiting Toxicity

    DLT evaluation period: The DLT evaluation period is defined as within 28 days (inclusive) after the subjects' first administration of KXV01 injection during the dose escalation stage. All adverse events should be graded and evaluated in accordance with CTCAE v5.0. Among them, cytokine release syndrome (CRS) and immune effector cell-related neurotoxicity syndrome (ICANS) should be determined and graded in accordance with the standards of the American Society for Transplantation and Cell Therapy (ASTCT).

    Measured: 28 days after administraiton

  2. The Occurrence of Adverse Events

    Any adverse medical event that occurs in patients or subjects of drug clinical research. It does not necessarily have a causal relationship with drug treatment or research procedures. Therefore, AE can be any adverse signs (including abnormal laboratory indicators), symptoms or diseases (new or aggravated) that are not related to the purpose of medication and have a temporal correlation with the investigational drug, regardless of whether these situations have a causal relationship with the investigational drug.

    Measured: From the signing of the informed consent form by the subjects until within 12 months after the administration of KXV01 injection, or when other anti-tumor treatment regimens have been initiated.

Timeline

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

  1. First posted6 Oct 2025
  2. Study start15 Oct 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07207681
Sponsor's protocol ID
KXV01-R101
Status last verified
Sep 2025
First submitted
1 Aug 2025
Last updated
6 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KXV01 TCR Lentinvivo Injection in people with Advanced Solid Tumors, run by The First Hospital of Jilin 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 18 inclusion and 49 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 6 Oct 2025. 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?

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 Jiuwei Cui (043188783173, chennaifei@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting Toxicity (time frame: 28 days after administraiton). 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 NCT07207681.

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 6 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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