Using immune cells to treat solid tumors in adults
A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours
This study is testing if injections of immune cells can help adults with advanced ovarian cancer feel better after their initial chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Grit Biotechnology Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06453057 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) injections in adults with solid tumors, specifically focusing on those with ovarian cancer that has progressed after initial chemotherapy. It is a single-arm, open-label design that aims to assess pharmacokinetics and efficacy to determine the optimal biological dose. Participants must meet specific eligibility criteria, including having measurable disease progression and a good performance status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with recurrent ovarian cancer that has progressed after first-line chemotherapy.
Not a fit: Patients with uncontrollable tumor-related pain or those requiring significant analgesic medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new immunotherapy option for patients with advanced ovarian cancer.
How similar studies have performed: While similar immunotherapy approaches have shown promise in treating various cancers, this specific application of GT307 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol; * 2\. Age 18 to 70 years old; * 3\. Ovarian cancer that progresses after recurrence or first-line chemotherapy； * 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; * 5\. Expected survival time of ≥ 12 weeks; * 6\. Good function of vital organs; * 7\. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling; * 8\. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling. Exclusion Criteria: * 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry; * 2.Known mental illness, alcoholism, drug use or substance abuse; * 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion; * 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study; * 5.The investigators determine that other conditions that make the patient not suitable for enrollment.
Where this trial is running
Shanghai, Shanghai Municipality
- Obstetrics & Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Kang Yu, PHD
- Email: kangyu1489@fckyy.org.cn
- Phone: +86 （021）63455050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.