Personalized KSX01-TCRT in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
This trial is a single arm, open phase I clinical study to investigate the safety and efficacy of personalized KSX01-TCRT in patients with advanced solid tumors. This experiment is divided into two parts: the dose increasing stage (Part A) and the dose expanding stage (Part B). For those enrolled in the planned expansion phase, the dose should have passed the safety assessment during the dose escalation phase.
Eligibility criteria
Qualifiers
Volunteer to participate in clinical research; Fully understand this study and voluntarily sign an informed consent form; Willing to follow and capable of completing all testing procedures.
Age range from 18 to 70 years old (including boundary values).
Solid tumors that have been confirmed by histological or cytological evaluation as incurable or metastatic, and have failed standard treatment or currently have no available standard treatment.
Expected survival time>6 months.
Disqualifiers
The second and third line systemic chemotherapy is defined as a systematic chemotherapy regimen after the progression of frontline treatment;
For patients who complete neoadjuvant chemotherapy in the early stage of their disease, their neoadjuvant chemotherapy regimen can include up to two types of chemotherapy;
For patients who meet all other inclusion criteria but have a large number of frontline treatment lines, they can also be included after evaluation and confirmation by the researchers.
Within two years before signing the informed consent, the patient had a medical history of other malignant tumors, except for non melanoma skin cancer, some cancers in situ (such as cervical cancer, bladder cancer, breast cancer), or low-risk prostate cancer.
Trial design
Treatments tested in this trial
- KSX01-TCRT cell therapy
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov