Using immune cells to treat advanced colorectal cancer
A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer
This study is testing if injections of immune cells can help people with advanced colorectal cancer who haven't responded to other treatments feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Grit Biotechnology Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06819280 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) injections in patients with advanced colorectal cancer who have not responded to first-line chemotherapy. It is a single-arm, open-label design that aims to assess the pharmacokinetics and efficacy of the treatment to determine the optimal biological dose. Participants will be monitored for their response to the therapy and overall health during the study period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with advanced colorectal cancer that has progressed after first-line chemotherapy.
Not a fit: Patients with uncontrollable tumor-related pain or those with significant mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced colorectal cancer who have limited treatment choices.
How similar studies have performed: Other studies using tumor-infiltrating lymphocytes have shown promise in treating various cancers, suggesting potential success for this approach in colorectal cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Jiaotong University School of Medcine, Renji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zheng Wang
- Email: wangzh1972@126.com
- Phone: 13501625681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.