Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Juncell Therapeutics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory/relapsed gynecologic tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with fludarabine and cyclophosphamide.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor Infiltrating Lymphocytes (TIL) | Experimental | 1x10^9-3x10^11 in vitro expanded autologous TILs will be infused i.v. to patients with relapsed/refractory malignant gynecological tumors after NMA lymphodepletion treatment with fludarabine and cyclophosphamide. PD-1 checkpoint inhibitor would be applied as combination treatment to those patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Infiltrating Lymphocytes (TIL) | Biological | Adoptive transfer of 1x10^9-3x10^11 autologous TILs to patients i.v. in 30-120 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Events (SAEs) | Safety assessments. Incidence of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs). The severity of all adverse events was graded based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | To evaluate the efficacy of TIL infusion in patients as determined by objective response rate (ORR), which contains complete response (CR) and partial response (PR), using the RECIST v1.1, as assessed by the Investigator. ( CT Scan at 4-6 weeks after TIL infusion, and than every 4-6 weeks for 1 year, and then every six months after that for up to 3 years) | Up to 36 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
This study is biologically possible only for females regardless of self-recognition of gender identity.
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Guo, PHd | Contact | +86 21 66307151 | jguo12@foxmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38769543 | Derived | Guo J, Wang C, Luo N, Wu Y, Huang W, Zhu J, Shi W, Ding J, Ge Y, Liu C, Lu Z, Bast RC Jr, Ai G, Yang W, Wang R, Li C, Chen R, Liu S, Jin H, Zhao B, Cheng Z. IL-2-free tumor-infiltrating lymphocyte therapy with PD-1 blockade demonstrates potent efficacy in advanced gynecologic cancer. BMC Med. 2024 May 20;22(1):207. doi: 10.1186/s12916-024-03420-0. | |
| 35177415 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Disease Control Rate (DCR) | Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1 | Up to 36 months |
| Duration of Response (DOR) | The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1 | Up to 36 months |
| Progression-Free Survival (PFS) | The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1 | Up to 36 months |
| Overall Survival (OS) | The length of time from the date of the start of TIL treatment that the patients are still alive | Up to 36 months |
| Complete Response(CR) | Patients with complete response per RECIST 1.1 to TIL treatment | Up to 36 months |
| Partial Response (PR) | Percentage of patients with partial response per RECIST 1.1 to TIL treatment | Up to 36 months |
| Stable Disease (SD) | Patients with stable disease per RECIST 1.1 to TIL treatment | Up to 36 months |
| Progressive Disease (PD) | Patients with progressive disease per RECIST 1.1 to TIL treatment | Up to 36 months |
| Guo J, Luo N, Ai G, Yang W, Zhu J, Li C, Chen R, Zhang C, Liu S, Jin H, Cheng Z. Eradicating tumor in a recurrent cervical cancer patient with autologous tumor-infiltrating lymphocytes and a modified lymphodepleting regimen. J Immunother Cancer. 2022 Feb;10(2):e003887. doi: 10.1136/jitc-2021-003887. |