225Ac-DOTA-daratumumab / City of Hope - LARVOL DELTA

NCI-2022-03039: Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Feb 2026 ➔ Mar 2027 | Trial primary completion date: Feb 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

NCI-2022-03039: Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=15 | Suspended | Sponsor: City of Hope Medical Center | Trial completion date: Mar 2025 ➔ Feb 2026 | Recruiting ➔ Suspended | Trial primary completion date: Mar 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Trial suspension • Hematological Malignancies • Multiple Myeloma • Oncology

225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2027 ➔ May 2028 | Initiation date: Oct 2024 ➔ Jan 2025 | Trial primary completion date: Feb 2027 ➔ May 2028

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

Mathematical Modeling Unveils Optimization Strategies for Targeted Radionuclide Therapy of Blood Cancers. (PubMed, Cancer Res Commun) - "Based on our experiments on disseminated multiple myeloma mouse model treated by 225Ac-DOTA-daratumumab, we developed a mathematical model which investigation highlighted the following principles for optimization of targeted radionuclide therapy. 3) Particle range-guided multi-dosing. The use of short-range particle emitters and high-affinity antibodies can allow for robust treatment optimization via initial saturation of cancer binding capacity, enabling redistribution of further injected radioconjugates and deposited dose towards still viable cells that continue expressing specific receptors."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: City of Hope Medical Center | Initiation date: Jun 2024 ➔ Oct 2024

Trial initiation date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

Mathematical modeling of targeted radionuclide therapy and CAR-T cell immunotherapy for maximizing therapeutic efficacy in multiple myeloma (AACR 2024) - "Using a preclinical disseminated mouse model of multiple myeloma (MM1S), we evaluate tumor response to 200 nCi of 225Ac-DOTA-Daratumumab (TRT) and 1 million cells of CS1 CAR-T cell therapy both as monotherapies as well as in combination. The proposed model demonstrates the impact of different dosing and scheduling regimens of TRT and CAR-T therapy on survival metrics. It is a potent tool for translating preclinical results to the clinic and eventually tailor therapy regimens for patients."

CAR T-Cell Therapy • Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P1 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

NCI-2022-03039: Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: City of Hope Medical Center | Suspended ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

NCI-2022-03039: Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=15 | Suspended | Sponsor: City of Hope Medical Center | Recruiting ➔ Suspended

Trial suspension • Hematological Malignancies • Multiple Myeloma • Oncology

NCI-2022-03039: Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology