Single Arm Clinical Study on the Safety and Efficacy of Personalized KSX01-TCRT in Patients With Advanced Solid Tumors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 site in 1 country12 target enrollmentNovember 7, 2023

ConditionsRefractory Solid Tumors Relapsed Solid Tumors

InterventionsKSX01-TCRT cell therapy

DrugsKSX01-TCRT cell therapy

Overview

Phase: Early Phase 1
Intervention: KSX01-TCRT cell therapy
Conditions: Refractory Solid Tumors
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Enrollment: 12
Locations: 1
Primary Endpoint: tumor efficacy
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 7, 2023

End Date

December 1, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Screening period 1- inclusion criteria:
•Patients should complete all examinations for screening period 1 within 28 days after signing the informed consent form. Only those who meet the inclusion criteria for this stage can collect fresh tumor tissue, 2-3 archived pathological tissue white slides, and peripheral blood for TCR sequence screening and HLA typing testing.
•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.
•ECOG score 0 or
•Having sufficient organ function, defined as follows:
•6.1) Hematology: 6.1.1) Hemoglobin 90 g/L (no blood transfusion received within 14 days prior to examination); 6.1.2) Absolute value of neutrophils 1.5 109/L (did not receive granulocyte colony stimulating factor treatment within 14 days prior to examination); 6.1.3) Platelet count is 100 109/L in the absence of obvious liver lesions (primary or metastatic) (platelet transfusion not received within 14 days before examination), or 75 109/L in the presence of liver lesions (platelet transfusion not received within 14 days before examination); 6.1.4) Absolute lymphocyte count (ALC) 0.7 109/L; 6.2) Liver function: 6.2.1) Total bilirubin (TBIL) ≤ 1.5 in the absence of obvious liver lesions (primary or metastatic) × Upper limit of normal (ULN), subjects with liver lesions or Gilbert disease ≤ 3 × ULN; 6.2.2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (liver metastasis or liver cancer subjects can be ≤ 5 × ULN); Alkaline phosphatase (ALP) ≤ 2.5 × ULN (bone metastasis subject, ALP ≤ 5) × ULN); 6.3) Renal function: Creatinine clearance rate ≥ 60 mL/min (Cockcroft Fault formula: \[140 age\] × Weight \[kg\] × \[0.85, female only\]/(72 × Creatinine (mg/dl);
•Subjects with a creatinine clearance rate of\<60 mL/min but ≥ 50 mL/min can also be enrolled if all of the following conditions are met:

Exclusion Criteria

•Screening period 1- Exclusion criteria:
•Subjects who meet any of the following criteria shall not participate in this clinical study:
•The patient has received systemic chemotherapy on line 3 or above:
•Patients can be enrolled during the first line systemic chemotherapy, during the second line systemic chemotherapy period, or after the end of the second line systemic chemotherapy (enrollment time is screening period 2 and meets the standards and receives clearance chemotherapy), but they cannot receive the third line systemic chemotherapy before enrollment:
•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.
•Frontline treatment plans targeting biological agents (such as immune checkpoint inhibitors), small molecule targeted drugs, etc., are not considered as exclusion criteria.
•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.
•Clinically confirmed liver diseases, including active hepatitis virus infection, alcoholic hepatitis, other types of hepatitis, cirrhosis, and hereditary liver diseases; Among them, the subject's