Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer
Recruiting · NCT06819280 · Interventional (participants receive a specific treatment) · Lead sponsor: Grit Biotechnology
View the official record on ClinicalTrials.gov →Interventions studied
GT307 injection
What this trial is 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).
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
Where it is running
1 location listed.
- Shanghai Jiaotong University School of Medcine, Renji Hospital - Shanghai, Shanghai Municipality, China