Actively Recruiting
A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours
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 therapy called GT307 in patients with solid tumors who have ovarian cancer that has progressed after recurrence or first-line chemotherapy. This single-arm, open design study also assesses pharmacokinetics and efficacy to find the optimal biological dose. The study is sponsored by Grit Biotechnology and focuses on adults aged 18 to 70 years with good overall health and expected survival of at least 12 weeks. Participants will receive injections of GT307 to treat their solid tumors. The study does not include a comparison group and monitors patients over time to evaluate how the treatment is tolerated and its effects on tumor response. Treatment involves tumor sampling, and patients must have measurable lesions as defined by RECIST v1.1. The study will collect data on adverse events and tumor response over a 3-year period. During the study, participants will undergo regular assessments including imaging to confirm disease progression before treatment and to monitor tumor response. Safety will be tracked using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Researchers will evaluate the objective response rate to treatment over three years. Participants will be monitored closely for side effects and overall health throughout the study period, which begins after enrollment and continues for up to three years.
CONDITIONS
Brief Title
Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily join the study, sign informed consent, and be willing and able to follow the study protocol
- Age between 18 and 70 years old
- Have ovarian cancer that has progressed after recurrence or first-line chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival time of at least 12 weeks
- Good function of vital organs
- Have imaging record of disease progression before tumor sampling if entering due to disease progression
- Have 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 at study entry; symptomatic lesions suitable for palliative radiotherapy should be treated before study entry
- Known mental illness, alcoholism, drug use, or substance abuse
- Pregnant or lactating women, or women planning pregnancy within 1 year after cell infusion
- Received other clinical trial drug treatment within 4 weeks before lymphodepletion preconditioning or plan to participate in other clinical trial drug treatments during this study
- Other conditions deemed unsuitable for enrollment by investigators
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 solid tumours.
Visits as needed for GT307 injection and monitoring
Trial Site Locations
Total: 1 location
1
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
K
Kang Yu, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here