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

NCT06453057 | Recruiting

• 1 other identifier: GRIT-CD-CHN-307-005
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Adult

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adcersed events per CTCAE 5.0

  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

  3 years

• Objective response rate

  To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

  3 years

Study Arms (1)

GT307 injection treatment group

EXPERIMENTAL

Biological: GT307 injection

Interventions

GT307 injection BIOLOGICAL

GT307 injection to treat solid tumours

GT307 injection treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
• \. Age 18 to 70 years old;
• \. Ovarian cancer that progresses after recurrence or first-line chemotherapy；
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• \. Expected survival time of ≥ 12 weeks;
• \. Good function of vital organs;
• \. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
• \. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

You may not qualify if:

• 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;
• Known mental illness, alcoholism, drug use or substance abuse;
• Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
• 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;
• The investigators determine that other conditions that make the patient not suitable for enrollment.

Sponsors & Collaborators

• Grit Biotechnology: lead

Study Sites (1)

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Central Study Contacts

Kang Yu, PHD

CONTACT

+86 （021）63455050; kangyu1489@fckyy.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 11, 2024
• Study Start: July 4, 2024
• Primary Completion (Estimated): June 6, 2027
• Study Completion (Estimated): June 6, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CN (1)