KSX01-TCRT Injection Project in Solid Tumors

NCT05811975 | Recruiting Early Phase 1

• 1 other identifier: KSX01-M101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1\) Safety and efficacy of TCR-T cells in subjects with refractory/relapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.

Conditions

TCR-T Cells; Refractory Solid Tumors; Relapsed Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Subject safety

  Number of participants with treatment-related adverse events assessed by CTCAE v4.0.

  about 2 years

• tumor efficacy

  Changes in overall tumor diameter.

  about 2 years

Study Arms (1)

TCR-T cells

EXPERIMENTAL

Drug: KSX01 injection individualization TCR-T cell injection

Drug: KSX01-TCRT injection

Interventions

KSX01-TCRT injection DRUG

individualization TCR-T cell injection

TCR-T cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Voluntary participation in clinical research; Fully understand the study and voluntarily sign an informed consent form; Willing to follow and capable of completing all test procedures.
• \) Age: 18 to 70 years old (including boundary value).
• \) Malignant solid tumors that have failed standard treatment or currently have no standard treatment available.
• \) Patients with tumor lesions that can be punctured and can be screened for a pharmaceutically acceptable TCR sequence can be enrolled in the study.

You may not qualify if:

• \) Adequate organ function (without medical support such as blood transfusion, granulocyte colony stimulating factor, etc. during pre harvest and baseline periods) is defined as follows:
• ) Blood system:
• ) Hemoglobin 90 g/L (no blood transfusion or erythropoietin treatment within 14 days before the first administration);
• ) The absolute value of neutrophils is 1.5 109/L (no treatment with granulocyte colony stimulating factor or granulocyte macrophage colony stimulating factor within at least 14 days before chemotherapy);
• ) Platelet count is 100 109/L in the absence of significant liver lesions (primary or metastatic), or 75 109/L in the presence of liver lesions (no platelet transfusion, thrombopoietin, or interleukin-11 treatment was received within 14 days before the first administration);
• ) Absolute lymphocyte count (ALC) 0.7 109/L;
• ) Liver function:
• ) Total bilirubin (TBIL) ≤ 2.0 in the absence of significant liver lesions (primary or metastatic) × Upper limit of normal (ULN), subjects with liver lesions or Gilbert disease ≤ 3 × ULN；
• ) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 × ULN (liver metastasis or hepatocellular carcinoma can be ≤ 5 × ULN）； Alkaline phosphatase (ALP) ≤ 2.5 × ULN (bone metastasis subject, ALP ≤ 5 × ULN）；
• ) Renal function:
• ) Creatinine clearance ≥ 50 ml/min (Cockcroft Gault formula: (\[140 age\] × Body weight \[kg\] × \[0.85, female only\])/(72 × Creatinine (mg/dl));
• ) Qualitative determination of urinary protein ≤ 1+; If the qualitative analysis of urine protein is ≥ 2+, a 24-hour urine protein quantitative test is required. If the 24-hour urine protein quantitative analysis is\<1 g, it is acceptable;
• ) Coagulation function: Activated partial thromboplastin time and international standardized ratio of 1.5 in patients who did not receive anticoagulant therapy × ULN, or patients receiving anticoagulation therapy, have a stable anticoagulation treatment regimen; Patients with liver metastasis or liver cancer are acceptable 2 × ULN。
• \) The Eastern United States Cancer Collaborative Group (ECOG) score for physical fitness is 0-1.
• \) The expected survival period is ≥ 12 weeks.

Sponsors & Collaborators

• TCRx Therapeutics Co.Ltd: lead

Study Sites (1)

The first affiliated hospital of Guang Xi medical university

Nanning, Guangxi, 530000, China

RECRUITING

Study Officials

• Jie Ma

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

clinical trials ksh

CONTACT

18994103369; ksh-clinicalt@tcrximmune.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 13, 2023
• Study Start: March 7, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)