Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated from a business perspective.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is an early exploration clinical study with one arm. The study consists of two stages, namely the dose escalation stage and the dose extension stage:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT307 injection treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous tumor infiltrating lymphocyte injection(GT201) | Biological | GT201 treatment for advanced gynecological tumors (advanced cervical cancer) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator | 3 years |
| Incidence and severity of adcersed events per CTCAE 5.0 | To characterize the safety profile of autologous TIL injection(GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0 | 3 years |
| Progression-Free Survival | To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator | 3 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiaotong University School of Medcine, Renji Hospital Ethica Committee | Shanghai | Shanghai Municipality | China |
Not provided
Not provided
Not provided
Not provided
Open label
Not provided