Sierra Clinical Trial Dosimetry Results Support Low Dose Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] for Targeted Lymphodepletion Prior to Adoptive Cell Therapy
Abstract
Introduction
Nearly all adoptive cell therapies currently being evaluated in the clinic, including CAR-T, TIL, and TCR-based cell therapies, require lymphodepletion to remove cellular cytokine sinks and create a favorable cytokine environment for the incoming transferred cells to proliferate. Targeted conditioning with an antibody radio-conjugate directed to CD45 represents a promising and potentially more effective alternative to the commonly used fludarabine/cyclophosphamide chemotherapy lymphodepletion regimen.
Methods
SIERRA is an ongoing Phase 3 multicenter trial evaluating anti-CD45 Iodine (131I) Apamistamab [Iomab-B] as targeted conditioning prior to HCT in active, relapsed or refractory acute myeloid leukemia. Prior to administration of the therapeutic dosage, dosimetry is performed using a tracer amount of Iomab-B (range from 7-20 mCi, median 10 mCi) in an out-patient setting to calculate the appropriate patient-specific therapeutic infusion. Blood sample analysis from 57 evaluable Iomab-B treated patients collected pre-dosimetric infusion (Pre-DI), post-dosimetric infusion (Post-DI), day 1 post-dosimetric infusion (D1 post-DI), and pre-therapeutic infusion (Pre-TI, range 6-14 days post-dosimetry) was assessed to determine if residual Iomab-B had any significant effect on blood counts in support of its use as a transient targeted lymphodepletion agent.
Results
From these data, a significant but transient decrease in lymphocytes and white blood cells was observed…
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