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

NCT06819280 | Recruiting

• 1 other identifier: GRIT-CD-CHN-307-007
• 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 Advanced Colorectal Cancer,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

GT307 injection treatment group

Biological: GT307 injection

Interventions

GT307 injection BIOLOGICAL

GT307 injection to treat Advanced Colorectal Cancer

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;
• 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.

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)

Shanghai Jiaotong University School of Medcine, Renji Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Zheng Wang

CONTACT

13501625681; wangzh1972@126.com

Study Design

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

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: June 28, 2024
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): May 27, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CN (1)