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

NCT ID: NCT06819280

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-28
• Study Completion Date: 2027-05-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GT307 injection treatment group

GT307 injection treatment group

Group Type: EXPERIMENTAL

GT307 injection

Intervention Type: BIOLOGICAL

GT307 injection to treat Advanced Colorectal Cancer

Interventions

GT307 injection

GT307 injection to treat Advanced Colorectal Cancer

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grit Biotechnology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Jiaotong University School of Medcine, Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zheng Wang

Role: CONTACT

wangzh1972@126.com

13501625681

Facility Contacts

Zheng Wang

Role: primary

wangzh1972@126.com

13501625681

Other Identifiers

GRIT-CD-CHN-307-007

Identifier Type: -

Identifier Source: org_study_id