An Open-label, Phase I Clinical Trial of Autologous T Cells Transduced With NY-ESO-1 Antigen-specific High-affinity T Cell Receptors in NY-ESO-1-positive Patients With Advanced Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Sign informed consent before conducting any trial-related activities;

• Age of 18-75 years old, male or female;

• Patients with first-line treatment failure;

• Measurable lesions according to RECIST1.1 criteria.

• During the trial screening period, the following two screening criteria must be met (by the sponsor) :

‣ HLA-A\*02 positive;

⁃ The positive rate of NYESO-1 immunohistochemical staining was ≥20%.

• ECOG score 0-1;

• The expected survival time is more than 3 months;

• Antineoplastic drugs and treatments were not allowed for 4 weeks before TCR-T cell infusion;

• Echocardiography showed left ventricular ejection fraction ≥50%;

⁃ Laboratory test results should at least meet the following specified indicators:

∙ WBC ≥3.0×109/L;

‣ Absolute neutrophil count (ANC) ≥1.5×109/L;

‣ Absolute lymphocyte count (ALC) ≥1.0×109/L;

‣ platelet (PLT) ≥75×109/L;

‣ hemoglobin ≥10g/dL (no blood transfusion in the past 7 days);

‣ Prothrombin time or INR≤1.5x upper limit of normal unless receiving anticoagulant therapy;

‣ Partial prothrombin time (APTT) ≤1.5x upper limit of normal time, unless receiving anticoagulant therapy;

‣ 24-hour creatinine clearance ≥60mL/ min;

‣ Aspartate aminotransferase (AST/SGOT) ≤2.5×ULN;

‣ alanine aminotransferase (ALT/SGPT) ≤2.5×ULN;

‣ Total bilirubin (TBIL) ≤1.5×ULN

⁃ Negative pregnancy tests in women of childbearing potential prior to study treatment; Consent must be given to use effective contraception during treatment.

⁃ During the whole period of the trial, I can regularly visit the enrolled research institutions for relevant testing, evaluation and management.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Ying Cheng
chengy02@fineimmu.com
86-02031605836
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2027-06-25
Participants
Target number of participants: 15
Treatments
Experimental: Dose escalation was performed in a 3+3 design
The Super1 TCR-T dose toxicity test was escalated according to the following dose (positive cells) escalation schedule:~Level 1 Level 2 Level 3
Sponsors
Leads: Guangzhou FineImmune Biotechnology Co., LTD.
Collaborators: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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