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Recruiting NCT06819280

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

No phase Interventional Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GT307 injection.
Who it may be relevant to
Registry conditions: Adult. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Biological GT307 injection
    GT307 injection to treat Advanced Colorectal Cancer

Primary outcome measures

  • Incidence and severity of adcersed events per CTCAE 5.0 [Time frame: 3 years]
  • Objective response rate [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Jiaotong University School of Medcine, Renji Hospital — Shanghai

Identifiers

NCT: NCT06819280 · GRIT-CD-CHN-307-007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗