Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Activated T lymphocyte · 2 trials · 2 indications
Progression-free survival was assessed locally by investigators on the basis of enhanced MRI was performed approximately 4 weeks after chemoradiotherapy, then at 10, 22, 34 and 46 weeks after randomization, and every 3\~12 months thereafter during the follow-up phase.
Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Disease control rate = CR or PR or SD patients / ITT population \*100
Of the 16 patients in the ITT population, stable disease(SD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.
Of the 16 patients in the ITT population, progressive disease (PD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.
| Arm | Type | Description |
|---|---|---|
| Control Group | NO_INTERVENTION | The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks. |
| Test Group | EXPERIMENTAL | The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times). |
| Immuncell-LC group | EXPERIMENTAL | Intravenous dripping of 200 ml (109\~2 1010 lymphocytes/60 kg adult) for 1 hour. |
| Name | Type | Description |
|---|---|---|
| Activated T lymphocyte(Immuncell-LC) | DRUG | Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109\~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions) |
| Activated T lymphocyte | BIOLOGICAL | Intravenous dripping of 200 ml (109\~2 1010 lymphocytes/60 kg adult) for 1 hour. |
Inclusion Criteria: 1. Patients who, prior to the study, received explanation of the purpose and content of study and of characteristics of the test drug from the test administrator and have consented to the study by providing signature of self, guardian, or legal representative. 2. Patients who ar...
Activated T lymphocyte is an investigational cell therapy being studied for the treatment of glioblastoma and pancreatic cancer. In glioblastoma, it is being evaluated in combination with temozolomide in newly diagnosed patients. In pancreatic cancer, it is being studied as a monotherapy in advanced disease. Both conditions are oncologic indications.
Activated T lymphocyte is being developed by Artiva Biotherapeutics, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol ARTV on the NASDAQ. Artiva is focused on developing cell therapies for oncology indications.
Activated T lymphocyte is in Phase 3 clinical development for glioblastoma, based on a completed Phase 3 trial. It has also completed a Phase 2 trial in pancreatic cancer. The drug is investigational and has not been approved by regulatory authorities.
Activated T lymphocyte has been studied in two completed clinical trials. NCT00807027 is a Phase 3 trial in glioblastoma with 180 participants, conducted in South Korea. NCT00965718 is a Phase 2 trial in pancreatic cancer with 20 participants, also conducted in South Korea. Both trials enrolled adults aged 18 and older.
Activated T lymphocyte is a cell therapy that involves the administration of activated T cells to treat cancer. The therapy is designed to enhance the immune system's ability to attack tumor cells. It is being studied in combination with temozolomide for glioblastoma and as a monotherapy for pancreatic cancer.