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NCT Number: NCT06819280

Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer

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 Advanced Colorectal Cancer,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).

Recruiting

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiaotong University School of Medcine, Renji Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Zheng Wang

CONTACT

[email protected]

13501625681

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily join the study, signed informed consent form, willing and able to comply with the study protocol;
  • Age 18 to 70 years old;
  • Advanced Colorectal Cancer that progresses after 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.

Exclusion criteria

  • 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

Treatment and study plan

GT307 injection

Biological

GT307 injection to treat Advanced Colorectal Cancer

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Zheng Wang

CONTACT

[email protected]

13501625681

Sponsors and collaborators

Lead sponsor

Grit Biotechnology

Industry

Registry information

Official study title

A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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