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

April 13, 2026 updated by: Grit Biotechnology

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200011
        • Recruiting
        • Obstetrics & Gynecology Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GT307 injection treatment group
Biological: GT307 injection
GT307 injection to treat solid tumours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 3 years
To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
3 years
Incidence and severity of adcersed events per CTCAE 5.0
Time Frame: 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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grit Biotechnology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2024

Primary Completion (Estimated)

June 6, 2027

Study Completion (Estimated)

June 6, 2027

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • GRIT-CD-CHN-307-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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