Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer
ConditionAdult
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGrit Biotechnology
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- GT307 injection
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov