Actively Recruiting
A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer
Led by Grit Biotechnology · Updated on 2026-04-14
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) in patients with advanced colorectal cancer whose disease has progressed after first-line chemotherapy. The study also assesses the pharmacokinetics and efficacy to determine the optimal biological dose of GT307. This is a single-arm, open-label clinical study sponsored by Grit Biotechnology. Participants will receive GT307 injection treatment during the study. The intervention involves administering the biological investigational product GT307 to target advanced colorectal cancer. The study does not include a comparator group and aims to observe responses and adverse events over time. During the study, participants will be monitored for the incidence and severity of adverse events using CTCAE 5.0 criteria over a period of three years. The objective response rate will also be measured during this time. Eligibility assessments include performance status, organ function, imaging to confirm disease progression, and measurable target lesions. Participants will be followed to evaluate safety, tolerability, and treatment response for up to three years.
CONDITIONS
Brief Title
Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily join the study and sign informed consent
- Age between 18 and 70 years old
- Have advanced colorectal cancer progressing after first-line chemotherapy
- ECOG performance status score of 0 or 1
- Expected survival time of at least 12 weeks
- Good function of vital organs
- Imaging record confirming disease progression before tumor sampling
- At least one measurable target lesion meeting RECIST v1.1 criteria after tumor sampling
You will not qualify if you...
- Uncontrollable tumor-related pain or unstable analgesic regimen
- Known mental illness, alcoholism, drug use, or substance abuse
- Pregnant or lactating women, or planning pregnancy within one year after treatment
- Participation in other clinical trial drug treatments within 4 weeks before lymphodepletion
- Any other conditions judged by investigators to make the patient unsuitable for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive GT307 injection to treat advanced colorectal cancer.
Visits scheduled according to treatment protocol
Trial Site Locations
Total: 1 location
1
Shanghai Jiaotong University School of Medcine, Renji Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Z
Zheng Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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