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

Not Applicable

Recruiting

• Conditions: Adult
• Interventions: Biological: GT307 injection

• Registration Number: NCT06819280
• Lead Sponsor: Grit Biotechnology

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-28
• Status Verified: 2025-02
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-11
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2027-05-27
• Study Completion: 2027-05-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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. Advanced Colorectal Cancer that progresses after 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GT307 injection treatment group	GT307 injection	GT307 injection treatment group

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Jiaotong University School of Medcine, Renji Hospital; 🇨🇳 Shanghai, Shanghai, China