NCT06453057 Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours
| NCT ID | NCT06453057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Grit Biotechnology |
| Condition | Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-07-04 |
| Primary Completion | 2027-06-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2024-07-04 with a primary completion date of 2027-06-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06453057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06453057 currently recruiting?
Yes, NCT06453057 is actively recruiting participants. Contact the research team at kangyu1489@fckyy.org.cn for enrollment information.
Where is the NCT06453057 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06453057 clinical trial?
NCT06453057 is sponsored by Grit Biotechnology. The trial plans to enroll 18 participants.