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Also known as 131I-apamistmab
Iomab-B · 2 trials · 10 indications
Graft failure defined as having had a primary or secondary graft failure by 42 days after blood stem cell (PB) transplantation. Primary graft failure is defined as failure to achieve an absolute neutrophil count (ANC) of \>500/ μL by 42 days after blood stem cell (PB) transplantation or a total donor chimerism of \>5%. Secondary graft failure is defined as cytopenias after initial engraftment (ANC \<500/μL) and a total donor cell chimerism decreasing to less than 5%.
| Arm | Type | Description |
|---|---|---|
| 131I-apamistmab-based nonmyeloablative conditioning | EXPERIMENTAL | Ten days before participants receive donor stem cell infusion, they will receive a dose of 131 I-apamistamab as an intravenous (IV) infusion into a vein in the arm. The 131 I-apamistamab product will be formulated in advance of the anticipated infusion date, for infusion on a specific date, based on target dose (100 mCi or 150 mCi, based on dose level). |
| Name | Type | Description |
|---|---|---|
| Iomab-B | DRUG | - |
| Conventional Care | DRUG | - |
| HCT | PROCEDURE | - |
| 131I-apamistmab | DRUG | 131I-apamistamab is a drug construct consisting of the apamistamab monoclonal antibody (mAb) and radioactive isotope iodine 131 (131I). The study drug will be patient-specific and will be manufactured for dosing on a specific date. The antibody dose will be at least 0.5mg/kg, however the final antibody amount may be higher if necessary based on the target radioactivity level. The 131I-apamistamab study drug requires patient details such as height, weight, a calculation to determine weight for use in calculating antibody amount for the dose. 131I-apamistmab will be given via intravenous (IV) infusion. |
| Sirolimus | DRUG | Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. It is an immunosuppressant agent. Sirolimus is to be given orally either as tablet or solution form. Dosage will be adjusted to a therapeutic target of 10-15 ng/mL in first 6 months post-transplant and 5-10 ng/mL after 6 months. |
| Campath | DRUG | Campath is a recombinant DNA-derived humanized monoclonal antibody that is directed against the 21-28 kD cell surface glycoprotein, CD52. CD52 is expressed on the surface of normal and malignant B and T lymphocytes, NK cells, monocytes, macrophages, and tissues of the male reproductive system. Campath will be given via IV at a total dose of 1 mg per kilogram of body weight. |
| Total Body Irradiation | DRUG | Radiation dose is 3Gy (Gy is a radiation unit of measurement). Radiation source and dose rates will be according to institutional practice. Total Body Irradiation (TBI) may be delivered from either linear accelerator or Cobalt sources. |
| Exchange Transfusion | PROCEDURE | Patient will undergo a red blood cell (RBC) exchange transfusion to achieve a Hemoglobin S (HgbS) level \< 20% prior to starting therapy to prevent the development of a vaso-occlusive Crisis (VOC). |
| Planar gamma imaging | RADIATION | Dosimetric imaging will be performed using quantitative planar gamma camera acquisition. Planar gamma imaging is a technique used in medical imaging to take pictures of the inside of the body, particularly to look at how certain organs or tissues are functioning. This allows the study doctor to evaluate how the study drugs are absorbed into the body. |
Inclusion Criteria: * Availability of an HLA-matched sibling donor * Patients with sickle cell anemia (Hb SS, Sβ0 thalassemia or severe SC) who are 12 - 50 years of age inclusive AND who have 1 or more of the following: 1. Clinically significant neurologic event (stroke) or any neurological defi...
Iomab-B is an investigational therapy being studied as conditioning treatment before hematopoietic stem cell transplant in older patients with active, relapsed or refractory acute myeloid leukemia. It is also being evaluated in a separate study for conditioning before stem cell transplant in advanced sickle cell disease. It is not approved and remains in clinical development.
Iomab-B targets CD45, an antigen expressed on most white blood cells, including leukemia cells. It is an iodine-131 labeled monoclonal antibody, so the CD45 binding delivers radiation directly to CD45-positive cells as part of transplant conditioning.
Iomab-B is being developed by Actinium Pharmaceuticals, Inc. (Delaware), which trades under the ticker ATNM.
Iomab-B is in Phase 3 development. The lead study is a Phase 3 trial in older patients with active, relapsed or refractory acute myeloid leukemia, and a separate Phase 1 study is evaluating it in advanced sickle cell disease. Iomab-B is investigational and has not been approved by the FDA.
Iomab-B has been studied in NCT02665065, a Phase 3 trial of Iomab-B versus conventional care in older subjects with active, relapsed or refractory acute myeloid leukemia, which enrolled 153 participants and is active but not recruiting. A Phase 1 study, NCT07015684, is recruiting to evaluate 131I-apamistamab-based conditioning for stem cell transplant in advanced sickle cell disease.
Yes, Iomab-B is also known as 131I-apamistamab. The two names refer to the same iodine-131 labeled anti-CD45 monoclonal antibody being developed by Actinium Pharmaceuticals for transplant conditioning.