Clinical trial · Interventional
Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer
A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer
NCT06819280CI-TRIAL-00108092recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GT307 injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GT307 injection treatment group
- description
- GT307 injection treatment group
- interventionNames
- Biological: GT307 injection
Primary outcomes (2)
- measure
- Incidence and severity of adcersed events per CTCAE 5.0
- timeFrame
- 3 years
- description
- To characterize the safety profile of autologous TIL injection（GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
- measure
- Objective response rate
- timeFrame
- 3 years
- description
- To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.