Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Activated T lymphocyte(Immuncell-LC), Immuncell-LC
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 in oncology for glioblastoma and pancreatic cancer. It is being developed by Artiva Biotherapeutics, Inc. (ticker ARTV) and is currently in Phase 3 development. The therapy is designed to treat patients with these advanced solid tumors.
Activated T lymphocyte targets F5 and F8 as an inhibitor. F5 and F8 are molecular targets in the coagulation pathway, and the therapy acts by inhibiting their activity. This targeted approach is being investigated for its role in treating glioblastoma and pancreatic cancer.
Activated T lymphocyte is being developed by Artiva Biotherapeutics, Inc., which trades under the ticker symbol ARTV. The company is advancing this cell therapy through clinical development for oncology indications, including glioblastoma and pancreatic cancer.
Activated T lymphocyte is in Phase 3 clinical development. It has not been approved by the FDA and remains investigational. The Phase 3 trial has been completed, and the therapy is being evaluated for the treatment of glioblastoma and pancreatic cancer.
Activated T lymphocyte has been studied in two completed clinical trials. NCT00965718 was a Phase 2 trial in advanced pancreatic cancer with 20 participants in South Korea. NCT00807027 was a Phase 3 trial in newly diagnosed glioblastoma with 180 participants, also in South Korea.
Yes, Activated T lymphocyte is also known as Immuncell-LC. The alternative name appears in the Phase 3 trial NCT00807027, which evaluated Immuncell-LC with temozolomide in newly diagnosed glioblastoma. Both names refer to the same cell therapy developed by Artiva Biotherapeutics.