Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tumor Infiltrating Lymphocyte · 1 trial · 5 indications
To characterize the safety profile of GC101 TIL in patients with advanced hepatobiliary-pancreatic cancers as assessed by incidence of adverse events.
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD. ( Except baseline evaluation within 28 days before TIL infusion，PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years)
Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST v1.1： DCR (proportion of patients) = # with CR + # with PR + # with SD / # with CR + # with PR + # with SD + # with PD.
The time length between the first confirmed objective response per RECIST 1.1 to the GC101 TIL treatment and the subsequent disease progression per RECIST 1.1
The time length between GC101 TIL infusion and confirmed subsequent disease progression according to RECIST 1.1
The length of time from the date of the start of GC101 TIL treatment that the patients are still alive.
| Arm | Type | Description |
|---|---|---|
| Tumor Infiltrating Lymphocytes | EXPERIMENTAL | 1x10\^9-5x10\^10 in vitro expanded autologous TILs will be infused i.v. to patients with advanced hepatobiliary-pancreatic cancers after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide. |
| Name | Type | Description |
|---|---|---|
| Tumor Infiltrating Lymphocyte | BIOLOGICAL | Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes. |
Inclusion Criteria: 1. Age: 18 years to 75 years; 2. Histologically diagnosed as primary/relapsed/metastasized hepatobiliary cancer or pancreatic cancers; 3. Expected life-span more than 3 months; 4. Karnofsky≥60% or ECOG score 0-2; 5. Test subjects have failed standard treatment regimens, or there...
Tumor Infiltrating Lymphocyte is an investigational cell therapy being studied for the treatment of advanced liver cancers, including advanced hepatobiliary-pancreatic cancers. It is currently in early Phase 1 clinical development and is not yet approved by regulatory authorities.
Tumor Infiltrating Lymphocyte is a monoclonal antibody modality, though its specific molecular target is not disclosed in available clinical trial information. The therapy is being evaluated for its effects on advanced liver cancers and related conditions.
Tumor Infiltrating Lymphocyte is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is conducting clinical research on this investigational therapy for advanced liver cancers.
Tumor Infiltrating Lymphocyte is in early Phase 1 clinical development. It is an investigational therapy and has not received FDA approval. The ongoing study is actively recruiting participants for the treatment of advanced liver cancers.
Tumor Infiltrating Lymphocyte is being studied in clinical trial NCT05098197, titled 'A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital)'. This early Phase 1 trial is recruiting 50 participants in China and is not randomized or blinded.
Yes, Tumor Infiltrating Lymphocyte is also known as GC101 TIL, as indicated in the clinical trial title. The study NCT05098197 evaluates GC101 TIL in patients with advanced hepatobiliary-pancreatic cancers, including advanced liver cancers.