Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Iodine-131 Anti-B1 Antibody · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment, Non-Randomized, Open Label | EXPERIMENTAL | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Name | Type | Description |
|---|---|---|
| Iodine-131 Anti-B1 Antibody | BIOLOGICAL | Dosimetric Dose: 450 mg unlabeled Anti-B1 Antibody infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody of which 1-2 mg has been labeled with 5 mCi of Iodine-131 infused over 20 minutes. Therapeutic Dose: 7-14 days after dosimetric dose, 450 mg Anti-B1 Antibody infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody labeled with the subject-specific dose of Iodine-131 to deliver the desired total body radiation, infused over 20 minutes The dose escalation will be initiated at 45 cGy and will be increased in 10 cGy increments until the maximum tolerated dose (MTD) is reached. |
Inclusion Criteria: * Patients must have a histologically confirmed initial diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to International Working Formulation (i.e., small lymphocytic \[with or without plasmacytoid differentiation\]; follicular small cleaved, or follicular, mixed s...
Iodine-131 Anti-B1 Antibody is an investigational monoclonal antibody being studied for the treatment of non-Hodgkin's lymphoma, specifically in patients with greater than 25% bone marrow involvement. It is a radioactive iodine-labeled antibody designed to target and deliver radiation to cancer cells.
Iodine-131 Anti-B1 Antibody is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for non-Hodgkin's lymphoma.
Iodine-131 Anti-B1 Antibody is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and effectiveness in patients with non-Hodgkin's lymphoma.
Iodine-131 Anti-B1 Antibody has one completed clinical trial, identified as NCT00992758. This Phase 1 study evaluated the safety and efficacy of the drug in 11 patients with non-Hodgkin's lymphoma who had greater than 25% bone marrow involvement. The trial was uncontrolled and not randomized or double-blinded.
Iodine-131 Anti-B1 Antibody is a monoclonal antibody that carries a radioactive isotope, iodine-131. It is designed to bind to a specific target on lymphoma cells and deliver localized radiation to destroy them. This approach aims to treat non-Hodgkin's lymphoma by directly targeting cancerous cells.