Personalized KXV01 TCR Lentinvivo Injection as the Therapy for Advanced Solid Tumors
ConditionAdvanced Solid Cancer
Trial statusNot yet recruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
KXV01 TCR Lentinvivo Injection
DrugKXV01 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: KXV01 TCR Lentinvivo InjectionExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
28 days after administraiton2
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.
Time frame
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 initiatedSponsors and contacts
Click on the lead sponsor to view all of their trials.
TCRx Therapeutics Co.Ltd
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: