Not Yet RecruitingNot Applicable

A Single-Arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT307) in the Treatment of Metastatic and Recurrent Advanced Solid Tumors

China16 participantsStarted 2026-04-30

Plain-language summary

This study adopts a single-center, single-arm, open-label design. It aims to evaluate the safety and tolerability of GT307 in patients with advanced solid tumors, as well as assess its pharmacokinetic profile and efficacy, and determine the optimal dosage regimen.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Routine blood tests: reference ranges are provided below, and final judgment may be made by the investigator considering variations in normal reference ranges across central laboratories:
✓. Liver function tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN. Criteria may be relaxed under the following conditions:
✓. Renal function tests: creatinine clearance (CrCL) ≥ 45 mL/min (calculated using the Cockcroft-Gault formula), or serum creatinine (Cr) within normal range; and urine protein (Pro) \< 2+.
✓. Coagulation function tests: APTT ≤ 1.5 × ULN, and international normalized ratio (INR) or PT ≤ 1.5 × ULN.
✓. Good cardiac function.
✓. Good pulmonary function.

Exclusion criteria

✕. Congestive heart failure (New York Heart Association \[NYHA\] class \> 2);
✕. Unstable angina;
✕. Myocardial infarction within the past 3 months;
✕. Any supraventricular or ventricular arrhythmia requiring treatment or intervention.

What they're measuring

Evaluation of the safety of GT307 in the treatment of advanced solid tumors

Timeframe: 24 months

Evaluation of the tolerability of GT307 in the treatment of advanced solid tumors

Timeframe: 24 months

Trial details

NCT IDNCT07534813

SponsorGrit Biotechnology

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-05-31

Contact for this trial

Jian Zhou

+86-21- 64041990 zhou.jian@zs-hospital.sh.cn

View on ClinicalTrials.gov More Advanced Solid Tumors trials