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Also known as BEXXAR
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-based oncology agent being developed by GSK plc for non-Hodgkin lymphoma. It combines an anti-B1 antibody with the radioisotope iodine-131, and it has been studied in patients with greater than 25% bone marrow involvement. It remains in clinical development and is not an approved therapy.
Iodine-131 Anti-B1 Antibody has been studied for the treatment of non-Hodgkin lymphoma, specifically in patients whose disease involves more than 25% of the bone marrow. That patient group was the focus of its Phase 1 trial. It is an investigational agent and is not approved for commercial use.
GSK plc, which trades under the ticker GSK, is the developer of Iodine-131 Anti-B1 Antibody. The company sponsored the clinical program evaluating the agent in non-Hodgkin lymphoma. No other developer or partnership for this asset has been disclosed.
Iodine-131 Anti-B1 Antibody is in Phase 1 development. Its only recorded clinical trial was a Phase 1 study, and that trial is now completed. The agent is investigational and has not been approved by the FDA for any indication.
Iodine-131 Anti-B1 Antibody was evaluated in trial NCT00992758, titled Safety and Efficacy of Iodine-131 Anti-B1 Antibody for Non Hodgkin's Lymphoma (NHL) Patients With Greater Than 25% Bone Marrow Involvement. The Phase 1 study enrolled 11 participants, was uncontrolled, and is completed. It enrolled adults aged 18 years and older of any sex.
No. The Phase 1 trial of Iodine-131 Anti-B1 Antibody, NCT00992758, was an uncontrolled study with no randomization and no double-blinding. It enrolled 11 patients with non-Hodgkin lymphoma and greater than 25% bone marrow involvement, and the study is completed.