Antibody Information
General Information of This Antibody
| Antibody ID | ANI0OMTIJ |
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| Antibody Name | MCLL0517A |
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| Antibody Type | Monoclonal antibody (mAb) |
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| Antibody Subtype | Humanized IgG1-kappa |
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| Antigen Name | C-type lectin domain family 12 member A (CLEC12A) |
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
RG6109 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible AML patients (excluding APL) must have ECOG 0-2 and adequate organ function. Arm A includes relapsed/refractory AML patients (≥18 years, ≤2 prior regimens), while Arm B enrolls treatment-naive patients (≥75 years or ≥65 years unfit for chemotherapy). Key exclusions include prior transplants, CNS leukemia, pulmonary diseases, recent investigational therapies, active infections (HCV/HBV/HIV), other recent malignancies, or QT prolongation risks.
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| Administration Dosage |
DCLL9718S will be administered as per the schedule specified in the respective arm.
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| Related Clinical Trial | |||||
| NCT Number | NCT03298516 | Clinical Status | PHASE1 | ||
| Clinical Description |
An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of DCLL9718S in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Patients With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy
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| Primary Endpoint |
The study evaluates safety outcomes including adverse event rates over 3 years and dose-limiting toxicities during the first treatment cycle (21-28 days depending on arm) to determine maximum tolerated dose and recommended phase 2 dose for DCLL9718S.
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| Other Endpoint |
Pharmacokinetic parameters of DCLL9718S and azacitidine are analyzed over 3 years, including serum/plasma concentrations, AUC, Cmax, clearance, half-life, and volume of distribution. Efficacy assessments per IWG criteria measure complete remission rates (CR/CRi/CRp), overall response, duration of response, overall survival, event-free survival, progression-free survival, and anti-drug antibody development.
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References