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131I-apamistmab · 1 trial · 1 indication
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 |
|---|---|---|
| 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...
131I-apamistmab is an investigational antibody-based therapy being studied for use in advanced sickle cell disease, specifically sickling disorder due to hemoglobin S. It is being evaluated as part of a conditioning regimen for hematopoietic stem cell transplant (HSCT) in patients aged 12 years and older.
131I-apamistmab is being developed by Actinium Pharmaceuticals, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol ATNM. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with advanced sickle cell disease.
131I-apamistmab is currently 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 potential effectiveness.
131I-apamistmab is being studied in a Phase 1 clinical trial with the identifier NCT07015684. This trial is evaluating 131I-apamistamab-based conditioning for hematopoietic stem cell transplant in advanced sickle cell disease. The study is currently recruiting participants in the United States and aims to enroll 24 patients.
131I-apamistmab is an antibody-based therapy, classified as a -mab (monoclonal antibody) drug. It is being investigated as part of a conditioning regimen for stem cell transplant, which prepares the patient's body to receive donor stem cells. The specific molecular target of the antibody has not been disclosed.
Yes, 131I-apamistmab and 131I-apamistamab refer to the same investigational drug. The name 131I-apamistmab is used in the drug's development records, while 131I-apamistamab appears in the clinical trial title. Both names denote the same antibody-based therapy being studied for sickle cell disease.