Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Immuncell-LC · 5 trials · 5 indications
Recurrence free survival is defined as the time from randomization to the date of the recurrence confirmed by independent reviewer
RFS was measured from the date of randomization to the first recurrence or to death from any cause.
RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.
Every 12 weeks from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
CT, PET-CT, MRI
The observation of maximum tolerated dose (MTD) or maximum feasible dose (MFD) evaluation(1X10\^7cell, 5X10\^7cell, 10X10\^7cells) of immuncell-LC on hepatocellular carcinoma patients who undergo liver transplantation
| Arm | Type | Description |
|---|---|---|
| Immuncell-LC/Gemcitabine | EXPERIMENTAL | Patients will receive 6 cycles Gemcitabine (1000 mg/m2 on Days 1, 8, 15, 28-day a cycle) and Immuncell-LC 16 times during 60 weeks (4 treatments once a week, followed by 4 treatments every other week, then 4 treatments every 4 weeks, and finally 4 treatments every 8 weeks) |
| Gemcitabine | ACTIVE_COMPARATOR | Patients will receive 6 cycles Gemcitabine alone (1000 mg/m2 on Days 1, 8, 15, 28-day a cycle) |
| Immunotherapy Group | EXPERIMENTAL | Adjuvant adoptive immune therapy using a CIK cell agent(Immuncell-LC) 16 times(4 treatments at a frequency of once per week, followed by 4 treatments every 2 weeks, then 4 treatments every 4 weeks, and finally 4 treatments every 8 weeks. |
| Control Group | NO_INTERVENTION | Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment |
| Immuncell-LC group | EXPERIMENTAL | Adjuvant adoptive immune therapy using a CIK cell agent(Immuncell-LC) 12 times(5 treatments at a frequency of once per week, followed by 5 treatments every 2 weeks, and finally 2 treatments every 4 weeks. |
| Non-treatment group | NO_INTERVENTION | Non-treatment |
| Name | Type | Description |
|---|---|---|
| Immuncell-LC | DRUG | IV |
| Gemcitabine | DRUG | IV |
Inclusion Criteria: 1. Age \>/=20 years old, \</=80 years old. 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma that fulfill the following requirements: * Participants have undergone a radical full resection (R0) or boundary resection (R1) operation and has elapsed ...
Immuncell-LC is an investigational small molecule being studied for use in hepatocellular carcinoma, advanced hepatocellular carcinoma, liver transplantation, and pancreatic ductal adenocarcinoma. It is being evaluated as a potential treatment for these conditions in clinical trials, though it is not yet approved for any indication.
Immuncell-LC is being developed by Artiva Biotherapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of Immuncell-LC in various oncology and transplant settings. Artiva Biotherapeutics trades on the stock exchange under the ticker symbol ARTV.
Immuncell-LC is in Phase 2 clinical development. It has completed Phase 1 and Phase 3 trials, and a Phase 2 trial is currently active. The drug is investigational and has not been approved by regulatory authorities. Its development is ongoing across multiple indications, including hepatocellular carcinoma and pancreatic cancer.
Immuncell-LC has been studied in several clinical trials. NCT00699816 is a completed Phase 3 trial in hepatocellular carcinoma with 230 participants. NCT02856815 is a completed Phase 2 trial in hepatocellular carcinoma with 76 participants. NCT03983967 is a completed Phase 1 trial in liver transplantation with 19 participants. NCT04969731 is an ongoing Phase 3 trial in pancreatic ductal adenocarcinoma with 408 participants.
Immuncell-LC is the primary name for this investigational drug. No alternative names have been reported for this asset. It is being developed by Artiva Biotherapeutics, Inc. and is distinct from other drugs in its class. The drug is being studied under this name across all its clinical trials.
Immuncell-LC is a small molecule therapeutic being developed for oncology indications. Its specific molecular target has not been disclosed in available information. The drug is being evaluated for its potential to treat hepatocellular carcinoma, pancreatic ductal adenocarcinoma, and to support patients undergoing liver transplantation, though its exact mechanism of action remains under investigation.