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Also known as HuM195-Ac225, Actimab-A
Lintuzumab-Ac225 · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Cytarabine (Phase 1 only) | DRUG | Low dose cytarabine administered at 20 mg subcutaneously every 12 hours for the first 10 days (Days 1 to 10) of every cycle. Cycle 1 can last up to 52 days (depending on the schedule of study drug dosing) in order to allow for recovery from Lintuzumab-Ac225. Cycles 2-12 will last 28 days each. |
| Lintuzumab-Ac225 | BIOLOGICAL | In Phase 1 the starting dose level was 1.0 μCi/Kg of Lintuzumab-Ac225 and 15 μg/Kg unlabeled HuM195 divided into 2 equal fractionated doses (0.5 μCi/Kg and 7.5 μg /Kg + 0.5 μCi/Kg and 7.5 μg /Kg) with the first fraction administered approximately 4-7 days after 1 cycle of low dose cytarabine and the second fraction administered 4-7 days after the first fraction, followed by up to 11 more cycles. In Phase 2 the dose will be 4.0 μCi/Kg Lintuzumab-Ac225 and 25 μg/Kg unlabeled HuM195 divided into 2 equal fractions with the first fraction given on Day 1 and the second fraction given on Day 5-8. |
| Furosemide (Phase 1 only) | DRUG | 40 mg by mouth daily one day prior to treatment with Lintuzumab-Ac225 and continuing for 10 days following administration of the 2nd divided dose. |
| Spironolactone | DRUG | 25 mg by mouth daily, administered 10 days after second dose of 225Ac-HuM195 and continued for 12 months. |
Lintuzumab-Ac225 is an investigational therapy being studied for acute myeloid leukemia (AML). It has been evaluated in older AML patients in a Phase 1/Phase 2 clinical trial. It is not approved for commercial use and remains in clinical development.
Lintuzumab-Ac225 targets CD33, a protein expressed on myeloid cells. The antibody component binds CD33 and delivers the Ac225 payload, an alpha-emitting radioisotope, to CD33-positive cells. This targeted approach is designed to direct radiation to leukemic cells in AML.
Lintuzumab-Ac225 is being developed by Actinium Pharmaceuticals, Inc., a company traded under the ticker ATNM. The company is advancing the asset as an investigational treatment for acute myeloid leukemia.
Lintuzumab-Ac225 is in Phase 2 development. It has completed a Phase 1/Phase 2 trial in older AML patients. The drug is investigational and has not been approved by the FDA for any indication.
Lintuzumab-Ac225 has been studied in one completed clinical trial, NCT02575963, titled "Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients." The trial was a Phase 1/Phase 2 study that enrolled 40 participants with AML and is now completed.
Lintuzumab-Ac225 is a radioimmunoconjugate that combines the anti-CD33 antibody lintuzumab with the alpha-emitting isotope Ac225. It is distinct from unconjugated lintuzumab, which does not carry a radioactive payload. The Ac225 conjugate is the specific investigational form being developed by Actinium Pharmaceuticals.