Drugs / Anti-CD45
Anti-CD45
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00078546 | Sep 2003 → Jan 2007 | Epstein-Barr virus infection, nasopharyngeal carcinoma | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT00057005 | Feb 2003 → Oct 2009 | leukemia | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT00579137 | Oct 2007 → Oct 2009 | Wiskott-Aldrich syndrome, severe combined immunodeficiency | Baylor College of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00056966 | Nov 2002 → May 2005 | hematopoietic and lymphoid cell neoplasm | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT00056979 | Jun 2002 → Jun 2003 | inborn errors of metabolism | Baylor College of Medicine | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2024-04-18 | Immedica Pharma AB | Results Immedica's partner Actinium announces Iomab-B phase 3 SIERRA trial results in patients with a TP53 mutation presented in an oral presentation at the 50th EBMT annual meeting immedica.com ↗
Iomab-B led alloHSCT significantly improved survival outcomes compared to conventional care in this very high-risk patient population with TP53 mutations. |
| 2022-04-19 | Actinium Pharmaceuticals | Results Actinium Pharmaceuticals, Inc. to Highlight Iomab-B Pivotal Phase 3 SIERRA Trial Data at the Transplantation & Cellular Therapy Tandem Meetings of ASTCT and CIBMTR actiniumpharma.com ↗
Data from the SIERRA trial has shown a consistent 100% rate of BMT access and engraftment in all patients receiving Iomab-B |
| 2021-11-04 | Actinium Pharmaceuticals | Results Actinium Announces Multiple Abstracts Highlighting Iomab-B and Actimab-A Accepted for Presentation at the 63rd Annual American Society of Hematology Annual Meeting actiniumpharma.com ↗
Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Conditioning Enables Hematopoietic Cell Transplantation with Successful Engraftment and Acceptable Safety in Active, Relapsed/Refractory AML Patients Not Responding to Targeted Therapies |
| 2021-06-15 | Actinium Pharmaceuticals | Results Pivotal Phase 3 SIERRA Trial Data Showing 100% Bone Marrow Transplant Engraftment in Patients Treated with Iomab-B presented at the 2021 Virtual SNMMI Conference actiniumpharma.com ↗
100% BMT and engraftment rate for patients receiving a therapeutic dose of Iomab-B compared to 18% of patients receiving physician's choice of salvage therapy on the control arm |
| 2021-06-15 | Actinium Pharmaceuticals | Results Safety Data Highlighting Low Rates of Adverse Events and Non-Relapse Transplant Related Mortality in Patients Receiving Iomab-B Presented at 2021 SNMMI Virtual Conference actiniumpharma.com ↗
The presentation highlighted Iomab-B's targeting ability and corresponding safety data from 113 patients, representing 75% of patient enrollment on the SIERRA trial. |
| 2021-02-11 | Actinium Pharmaceuticals | Results Actinium Showcases Targeted Conditioning Program with 2 Oral Presentations Highlighting Iomab-B and Pivotal Phase 3 SIERRA Trial at 2021 Transplantation & Cellular Therapy Annual Meeting actiniumpharma.com ↗
Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Older Patients with Active, Relapsed or Refractory (R/R) Acute Myeloid Leukemia Results in Successful and Timely Engraftment Not Related to the Radiation Dose Delivered |
| 2020-12-07 | Actinium Pharmaceuticals | Results Actinium Announces Positive Interim Results from Iomab-B Pivotal Phase 3 SIERRA Trial at 75% of Total Patient Enrollment at the 62nd American Society of Hematology Annual Meeting actiniumpharma.com ↗
In total, 78% (88/113) of patients enrolled on the SIERRA trial were able to receive a BMT despite this being a patient population not typically considered for BMT. |
| 2020-12-07 | Actinium Pharmaceuticals | Results Actinium Highlights Iomab-B Safety Data Presented at the 62nd American Society of Hematology Annual Meeting actiniumpharma.com ↗
In addition, patients that crossed over to receive Iomab-B and went to BMT after receiving salvage therapy but not achieving a complete response also had lower rates of sepsis, febrile neutropenia, mucositis and non-relapse transplant related mortality. |
| 2020-12-03 | Actinium Pharmaceuticals | Results Actinium Highlights Clinical Data to be Presented at the Upcoming 62nd American Society of Hematology Annual Meeting actiniumpharma.com ↗
Personalized Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia Results in Successful Donor Hematopoietic Cells Engraftment with the Timing of Engraftment Not Related to the Radiation Dose Delivered |
| 2020-11-04 | Actinium Pharmaceuticals | Results Actinium Announces Two Oral Presentations Featuring Data and Findings from the Phase 3 SIERRA Trial of Iomab-B at the 62nd American Society of Hematology Annual Meeting actiniumpharma.com ↗
We are encouraged that we continue to see positive ongoing results from our Phase 3 pivotal SIERRA trial in relapsed or refractory Acute Myeloid Leukemia (R/R AML) patients. |
| 2019-06-25 | Actinium Pharmaceuticals | Results Actinium Presents New Data Demonstrating Effective Lymphodepletion with Lutetium-177 for CAR-T at the 2019 Society of Nuclear Medicine and Molecular Imaging Annual Meeting actiniumpharma.com ↗
In vivo animal studies demonstrated that a Lu-177 labeled CD45 ARC transiently depleted CD45 positive immune cells while sparing platelets, red blood cells and bone marrow cells. |
| 2019-05-16 | Actinium Pharmaceuticals | Results Abstract Highlighting New Data from the Iomab-B Pivotal Phase 3 SIERRA Trial to be Presented at 2019 ASCO Annual Meeting actiniumpharma.com ↗
This significant and rapid reduction in blasts occurred with patients receiving only a single therapeutic infusion of Iomab-B and no other pre-transplant conditioning. |
| 2019-02-21 | Actinium Pharmaceuticals | Results Actinium Highlights New Data at TCT Meetings Demonstrating Effective Lymphodepletion Supporting Iomab-ACT Program Development for Targeted Conditioning Prior to CAR-T and Adoptive Cell Therapy actiniumpharma.com ↗
A series of preclinical studies demonstrated that targeting CD45 with an ARC or Antibody Radiation-Conjugate can achieve potent yet transient lymphodepletion in a safe and effective manner. |
| 2018-12-04 | Actinium Pharmaceuticals | Results Actinium Pharmaceuticals Highlights Analysis of Pivotal Iomab-B Phase 3 SIERRA Trial Presented in Oral Session at ASH Annual Meeting actiniumpharma.com ↗
Preliminary data strongly support the feasibility and safety of re-induction and targeted conditioning with Iomab-B prior to a BMT. |
All press releases naming this drug 14 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Anti-CD45 | “Anti-CD45 is a combination in equal amounts (weight for volume) of two monoclonal antibodies that are directed to non-overlapping epitopes on human CD45.” NCT00078546 ↗ |
| Known as | YTH 54 | “Anti-CD45 (YTH-24 & YTH 54) and ANTI-CD52 (CAMPATH-1H) Monoclonal Antibody Conditioning Regimen” NCT00056979 ↗ |
| Known as | YTH-24 | “Anti-CD45 (YTH-24 & YTH 54) and ANTI-CD52 (CAMPATH-1H) Monoclonal Antibody Conditioning Regimen” NCT00056979 ↗ |
| Action | Deplete | “Anti-CD45 may help in eradicating residual malignant cells.” NCT00056966 ↗ |
| Modality | Protein / enzyme biologic | “Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells” NCT00056966 ↗ |
| Route | Intravenous | “Anti-CD45 will be given as a daily IV infusion for 4 days.” NCT00056966 ↗ |