Details of the SBP
| General Information of Synthetic Binding Protein (SBP) (ID: SBP000153) | ||||||
|---|---|---|---|---|---|---|
| SBP Name |
DART Flotetuzumab
|
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| Synonyms |
CD123 x CD3 DART Bi-Specific Antibody MGD006; CD123 x CD3 Dual Affinity Re-Targeting Bi-Specific Antibody MGD006; MGD006; RES234; S80880
|
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| Molecular Weight | 58.9 kDa | |||||
| Design Method | Traditional methods (Site-directed mutagenesis and/or Directed evolution) | |||||
| Highest Status | Phase II | |||||
| Sequence Length | 552 | |||||
| SBP Sequence |
>A Chain
DFVMTQSPDSLAVSLGERVTMSCKSSQSLLNSGNQKNYLTWYQQKPGQPPKLLIYWASTR ESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQNDYSYPYTFGQGTKLEIKGGGSGGG GEVQLVESGGGLVQPGGSLRLSCAASGFTFSTYAMNWVRQAPGKGLEWVGRIRSKYNNYA TYYADSVKDRFTISRDDSKNSLYLQMNSLKTEDTAVYYCVRHGNFGNSYVSWFAYWGQGT LVTVSSGGCGGGKVAALKEKVAALKEKVAALKEKVAALKE >B Chain XAVVTQEPSLTVSPGGTVTLTCRSSTGAVTTSNYANWVQQKPGQAPRGLIGGTNKRAPWT PARFSGSLLGGKAALTITGAQAEDEADYYCALWYSNLWVFGGGTKLTVLGGGGSGGGGEV QLVQSGAELKKPGASVKVSCKASGYTFTDYYMKWVRQAPGQGLEWIGDIIPSNGATFYNQ KFKGRVTITVDKSTSTAYMELSSLRSEDTAVYYCARSHLLRASWFAYWGQGTLVTVSSGG CGGGEVAALEKEVAALEKEVAALEKEVAALEK |
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| Protein Scaffold Information of This SBP | ||||||
|---|---|---|---|---|---|---|
| Scaffold ID | PS028 | [1] , [2] | ||||
| Scaffold Name | DART | |||||
| Scaffold Class | Antibody fragment | |||||
| Fold Type | Beta-Sheets + Loops | |||||
| Binding Target(s) of This SBP (BTS) |
|---|
| BTS Name | Details | Mechanism | Application | Affinity | Research Organization | Ref |
|---|---|---|---|---|---|---|
| T-cell surface glycoprotein CD3 | Binder | Acute myeloid leukaemia [ICD-11: XH8AA5]; Myelodysplastic syndrome (MDS) [ICD-11: 2A3Z] | N.A. | MacroGenics; Servier | [1] , [2] | |
| Interleukin-3 receptor subunit alpha | Binder | Acute myeloid leukaemia [ICD-11: XH8AA5]; Myelodysplastic syndrome (MDS) [ICD-11: 2A3Z] | N.A. | MacroGenics; Servier | [1] , [2] | |
| Clinical Trial Information of This SBP | ||||||
|---|---|---|---|---|---|---|
| NCT02152956 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS) | |||||
| Phase | Phase I; Phase II | |||||
| Title | A Phase I/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART? Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS) | |||||
| Status | Recruiting | |||||
| Sponsor | MacroGenics | |||||
| NCT03739606 | Click to show the Detail | |||||
| Indication | Advanced CD123-Positive Hematological Malignancies | |||||
| Phase | Phase II | |||||
| Title | A Phase II Study to Evaluate the Anti-Tumor Activity of Single Agent?Flotetuzumab?in Advanced CD123-Positive Hematological Malignancies | |||||
| Status | Withdrawn?(RSS recommendation) | |||||
| Sponsor | City of Hope Medical Center | |||||
| NCT04158739 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Acute Myeloid Leukemia | |||||
| Phase | Phase I | |||||
| Title | A Phase I Trial of the CD123 X CD3 DART Molecule?Flotetuzumab?(NSC#808294) in Children, Adolescents, and Young Adults With Relapsed or Refractory Acute Myeloid Leukemia | |||||
| Status | Recruiting | |||||
| Sponsor | Children's Oncology Group | |||||
| NCT04582864 | Click to show the Detail | |||||
| Indication | Relapsed Acute Myeloid Leukemia (AML) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Trial Evaluating the Efficacy of?Flotetuzumab?(MGD006) for Relapsed Acute Myeloid Leukemia (AML) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) | |||||
| Status | Not recruiting | |||||
| Sponsor | Washington University School of Medicine | |||||
| NCT04678466 | Click to show the Detail | |||||
| Indication | Acute Myeloid Leukemia (AML) | |||||
| Phase | . | |||||
| Title | An Expanded Access Program Providing Flotetuzumab in the Treatment of Acute Myeloid Leukemia Patients in Single, Individually-approved Patients | |||||
| Status | Available | |||||
| Sponsor | MacroGenics | |||||
| NCT04681105 | Click to show the Detail | |||||
| Indication | Advanced CD123-Positive Hematological Malignancies | |||||
| Phase | Phase I | |||||
| Title | A Phase I Trial to Evaluate the Safety of Single Agent?Flotetuzumab?in Advanced CD123-Positive Hematological Malignancies | |||||
| Status | Recruiting | |||||
| Sponsor | City of Hope Medical Center | |||||
| NCT05063123 | Click to show the Detail | |||||
| Indication | AML | |||||
| Phase | Phase II | |||||
| Title | Study to Assess an Interphase Cycle With Flotetuzumab. | |||||
| Status | Withdrawn | |||||
| Sponsor | Stichting Hemato-Oncologie voor Volwassenen Nederland | |||||
| NCT05506956 | Click to show the Detail | |||||
| Indication | Leukemia, Myeloid, Acute | |||||
| Phase | Phase I | |||||
| Title | Post-transplant Flotetuzumab for AML | |||||
| Status | Recruiting | |||||
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||||