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Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours

NCT06453057 — Not applicable, Recruiting, 18 participants, Grit Biotechnology

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A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours

RegistryNCT06453057
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment18 (Estimated)
SponsorGrit Biotechnology (Industry)
ConditionsAdult
InterventionsGT307 injection (Biological)
Datesstart 2024-07-04, primary completion 2027-06-06 (estimated), completion 2027-06-06 (estimated), first posted 2024-06-11, last updated 2026-04-14
Locations1 site in China

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-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).

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+Arms and interventions

ArmTypeInterventionsDescription
GT307 injection treatment groupExperimentalBiological: GT307 injection
  • GT307 injection (Biological): GT307 injection to treat solid tumours

+Outcome measures

Primary outcomes

  • Incidence and severity of adcersed events per CTCAE 5.0 [3 years]: To characterize the safety profile of autologous TIL injection(GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
  • Objective response rate [3 years]: To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Obstetrics & Gynecology Hospital of Fudan UniversityShanghai, Shanghai MunicipalityChinaRecruiting

My Notes