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

NCT07196579 | Not Yet Recruiting Phase 1

• 1 other identifier: KXV01-R101
• 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 Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• The Occurence 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.

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

Study Arms (1)

KXV01 TCR Lentinvivo Injection

EXPERIMENTAL

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

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, defined as follows:
• ) 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.
• ) 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:

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.
• 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;

Sponsors & Collaborators

• TCRx Therapeutics Co.Ltd: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230001, China

Location

Central Study Contacts

Beicheng Sun Executive Dean

CONTACT

055162922800; sunbc0207@163.com

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: July 22, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)