KSH01-TCRT Solid Tumors

NCT05539833 | Recruiting Early Phase 1

• 1 other identifier: KSH01-TCRT-01
• 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)

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

  Subject safety

  about 2 years

• Changes in overall tumor diameter.

  tumor efficacy

  about 2 years

Secondary Outcomes (5)

• Anti-tumor efficacy

  about 5 years

• Pharmacokinetic profile

  about 2 years

• Cytokine profile

  about 2 years

• Biomarker Features profile

  about 2 years

• Maximum tolerated dose in subjects.

  about 2 years

Study Arms (1)

TCR-T cells

EXPERIMENTAL

Drug: KSH01 injection

Interventions

KSH01 injection DRUG

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:

• Voluntarily participate in clinical research; fully understand this research and sign informed consent voluntarily; be willing to follow and have the ability to complete all experimental procedures;
• Male or female, aged 18 to 70 years (inclusive);
• Subjects with advanced malignant solid tumors confirmed by histology or cytology;
• Dose escalation phase: subjects who have no standard treatment, or who have failed or relapsed after standard treatment, or who cannot tolerate standard treatment with positive target expression;
• Dose expansion phase: target-positive subjects who progressed on first-line therapy;
• HLA-A\*02 positive and tumor target positive (target tumor cell staining intensity is divided into 0, 1+, 2+, 3+, \>30% of cancer cells express 2+ or 3+ positive positive for the target)

You may not qualify if:

• Sufficient organ function (without receiving medical support such as blood transfusion and granulocyte colony-stimulating factor within 14 days before cell reinfusion), defined as follows:
• Blood system:
• The neutrophil count (ANC) is not lower than the lower limit of the normal value of the center;
• White blood cells (WBC) are not lower than the lower limit of the normal value of the center;
• Platelet count (PLT) is not lower than the lower limit of normal value in our center;
• Hemoglobin (Hb) not less than 0.8\*LLN (lower limit of normal);
• Liver function:
• Total bilirubin (TBIL) ≤ 2.0 × upper limit of normal (ULN), Gilbert disease subjects should be ≤ 3 × ULN;
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤3×ULN (in the dose expansion phase, subjects with liver metastases or liver cancer can be ≤5×ULN); alkaline phosphatase (ALP) ≤2.5× ULN (subjects with bone metastases, ALP≤5×ULN);
• Renal function:
• Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula: (\[140-age\]×weight \[kg\]×\[0.85, for women only\])/(72×creatinine (mg/dl)));
• The qualitative urine protein is ≤1+; if the qualitative urine protein is ≥2+, a 24-hour urine protein quantitative examination is required, and if the 24-hour urine protein quantitative \<1 g, it is acceptable;
• Coagulation function:
• Those who did not receive anticoagulation therapy: International normalized ratio (INR), activated partial thromboplastin time (APTT) should be less than or equal to 1.5×ULN; patients with liver metastasis or liver cancer should be less than or equal to 2×ULN;
• Physical status: Eastern Cooperative Oncology Group (ECOG) score of 0-1;

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: September 7, 2022
• First Posted: September 14, 2022
• Study Start: August 19, 2022
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)