KXV01 Injection in Patients With Advanced Solid Tumor (Including Osteosarcoma and Sarcoma)

NCT07596693 | Recruiting Phase 1

• 1 other identifier: KXV01-R102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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).

  28 days after administraiton

Study Arms (1)

KXV01 TCR Lentinvivo Injection

EXPERIMENTAL

KXV01 TCR Lentinvivo Injection

Drug: KXV01 TCR Lentinvivo Injection

Interventions

KXV01 TCR Lentinvivo Injection DRUG

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.

KXV01 TCR Lentinvivo Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• TCRx Therapeutics Co.Ltd: lead
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator

Study Sites (1)

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

Shanghai, 200233, China

RECRUITING

Central Study Contacts

Weichi Zhou

CONTACT

+86-18994103369; zhouwc@tcrximmune.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: December 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)