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Clinical Trials in China / NCT06819280
Recruiting Not applicable

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

NCT06819280 · tracked via the Priya Life Science China tracker
Sponsor
Grit Biotechnology
Phase
Not applicable
Started
2024-06-28
Last updated
2026-04-14

Condition(s) studied

Adult

Investigational drug(s) / intervention(s)

GT307 injection

GT307 injection: GT307 injection to treat Advanced Colorectal Cancer

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Jiaotong University School of Medcine, Renji Hospital Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06819280 on ClinicalTrials.gov ↗ ← All trials in China