KXV01 Injection in Patients With Advanced Solid Tumor (Including Osteosarcoma and Sarcoma)
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTCRx Therapeutics Co.Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- KXV01 TCR Lentinvivo Injection
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
TCRx Therapeutics Co.Ltd
Lead sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborator
Source ClinicalTrials.gov