Using immune cells to treat solid tumors in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.