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

Grit Biotechnology

Status: Enrolling

Conditions: Adult

Treatments: Biological: GT307 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06819280

GRIT-CD-CHN-307-007

Details and patient eligibility

About

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).

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

GT307 injection treatment group

Experimental group

Description:

GT307 injection treatment group

Treatment:

Biological: GT307 injection