Advanced Solid TumorsPhase 1NCT07596693
KXV01 Injection in Patients With Advanced Solid Tumor (Including Osteosarcoma and Sarcoma)
A Phase 1 study testing KXV01 TCR Lentinvivo Injection in people with Advanced Solid Tumors, run by TCRx Therapeutics Co.Ltd at 1 site in China.
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
- 19 Dec 2025to 31 Dec 2029
- 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.
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- Patients whose tumor lesions can be collected and from whom tumor-reactive TCR sequences can be identified may enter the 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.
- Females who are pregnant or breastfeeding.
- A history of primary immunodeficiency or autoimmune disease.
- 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 investigatory 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).
- 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 restricted drugs or treatments between Screening Period 1 and Screening Period 2 per the protocol.
- Females who are pregnant or breastfeeding.
- Subjects whose underlying condition, in the investigator's judgment, may increase the risk of receiving the investigatory 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.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, 200233
HaiYan Hu, M.D., 021-64369181, zhouwc@tcrximmune.cn
About this study
Official title: A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KXV01 Injection in Patients With Advanced Solid Tumor (Including Osteosarcoma and Sarcoma)
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.
- Conditions
- Advanced Solid Tumors
- 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 group | Role | What they receive |
|---|---|---|
| KXV01 TCR Lentinvivo Injection | Experimental | KXV01 TCR Lentinvivo Injection Receives: Drug: KXV01 TCR Lentinvivo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity
DLT evaluation period: The DLT evaluation period is defined as within 28 days (inclusive) after the subjects' first infusion 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start19 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TCRx Therapeutics Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596693
- Sponsor's protocol ID
- KXV01-R102
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KXV01 Injection in Patients With Advanced Solid Tumor (Including Osteosarcoma and Sarcoma)
- ClinicalTrials.gov ID
- NCT07596693
- Acronym / sponsor ID
- KXV01-R102
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- TCRx Therapeutics Co.LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 May 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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KXV01 TCR Lentinvivo Injection | Experimental | Drug: KXV01 TCR Lentinvivo InjectionKXV01 TCR Lentinvivo Injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
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 |
|---|---|---|
| KXV01 TCR Lentinvivo InjectionKXV01 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. | Drug | KXV01 TCR Lentinvivo Injection |
Primary outcome
Dose-limiting Toxicity
Time frame: 28 days after administraiton
DLT evaluation period: The DLT evaluation period is defined as within 28 days (inclusive) after the subjects' first infusion 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).
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 19 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
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 TCRx Therapeutics Co.Ltd 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 17 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 19 May 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?
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 Weichi Zhou (+86-18994103369, zhouwc@tcrximmune.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). 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 19 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.