A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours
| Registry | NCT06453057 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 18 (Estimated) |
| Sponsor | Grit Biotechnology (Industry) |
| Conditions | Adult |
| Interventions | GT307 injection (Biological) |
| Dates | start 2024-07-04, primary completion 2027-06-06 (estimated), completion 2027-06-06 (estimated), first posted 2024-06-11, last updated 2026-04-14 |
| Locations | 1 site in China |
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This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| GT307 injection treatment group | Experimental | Biological: GT307 injection |
Sex: All, ages: 18 Years to 70 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Obstetrics & Gynecology Hospital of Fudan University | Shanghai, Shanghai Municipality | China | Recruiting |