Phase I Study of Escalating Doses of 90Y-DOTA-Anti-CD25 Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan, and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Leukemia or Myelodysplastic Syndrome
The Phase I trial of 90Y-DOTA-anti-CD25 basiliximab, in combination with fludarabine, melphalan, and total marrow and lymphoid irradiation (TMLI), aims to enhance outcomes for patients with high-risk acute leukemia or myelodysplastic syndrome. Given the high unmet need in this patient population, successful results could position the asset favorably in the hematologic malignancy treatment landscape. The collaboration with the National Cancer Institute (NCI) may enhance credibility and facilitate future funding opportunities. However, the competitive landscape includes established therapies and emerging agents targeting similar pathways, necessitating a robust differentiation strategy. The trial's focus on a specific patient demographic (age ≥ 60 years or younger with comorbidities) may limit market size but could also streamline regulatory pathways if successful.
Indication: Acute Lymphoblastic Leukemia
Modality: protein therapy
Target: CD25 positive cancer cells
Sponsor: City of Hope Medical Center
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 17, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: CD25 positive cancer cells
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Condition raw: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Secondary Acute Myeloid Leukemia
Condition normalized: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Secondary Acute Myeloid Leukemia
Modality raw: protein therapy
Modality normalized: protein therapy
Target raw: CD25 positive cancer cells
Target normalized: CD25 positive cancer cells