| Product Name | Camidanlumab ELISA Kit |
|---|---|
| Synonyms | ADCT-301(unconjugated), HuMax-TAC-ADC, CAS: 921618-45-3 |
| Method | Quantitative |
| Detection Range | 0.31-5 μg/mL |
| Sensitivity | 0.156 μg/ml |
| Sample Types | Plasma, Serum |
| Reconstitution | Detection method: Colorimetric. Recovery: 80-120%. Specifications: Camidanlumab |
| Storage | The stability of ELISA kit is determined by the loss rate of activity. The loss rate of this kit is less than 10% prior to the expiration date under appropriate storage condition. |
| Notes | Detection method: Colorimetric. Recovery: 80-120% |
| Background | Camidanlumab tesirine is an antibody-drug conjugate against CD25, an antigen expressed in several malignancies, including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). This open-label, dose-escalation and -expansion study (NCT02588092) assessed the safety, activity, pharmacokinetics (PK), and immunogenicity of camidanlumab tesirine in patients with relapsed/refractory ALL/AML. A total of 35 patients (34 AML and 1 ALL) were enrolled and received camidanlumab tesirine intravenously at 3-92 μg/kg once every three weeks (Q3W, n = 26) or 30 or 37.5 μg/kg every week (QW, n = 9). One dose-limiting toxicity of maculopapular rash occurred in the 30 μg/kg QW group; the maximum tolerated dose was not reached. No additional safety concerns or adverse events (AEs) of interest were identified. The most common (>10 % of patients) Grade ≥3 treatment-emergent AEs were febrile neutropenia (25.7 %), lymphopenia, neutropenia, thrombocytopenia or fatigue (all 14.3 %), pneumonia, increased gamma-glutamyltransferase, and hypophosphatemia (each 11.4 %). No signal for serious immune-related AEs such as Guillain-Barré syndrome/polyradiculopathy was observed and there was no evidence of immunogenicity. PK showed rapid clearance with apparent half-life <2 days for conjugated and total antibody, suggesting that Q3W dosing may be insufficient for therapeutic efficacy, and prompting exploration of a QW schedule. Two patients achieved complete responses with incomplete hematologic recovery; one each at 30 and 37.5 μg/kg QW. The trial was terminated during dose escalation due to programmatic reasons other than safety. Hence, recommended dose was not determined. |
| Supplier | ARP |
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