Table 4.
Clinical trials of anti-CD123 mAbs in myeloid neoplasms.
| Disease type and inclusion criteria | Drug or drug combination, other therapies | Outcome measures | (Estimated) enrollment | Clinical trials identifier | Trial status |
|---|---|---|---|---|---|
| AML in first remission, high risk of relapse, patients not eligible for post-remission chemotherapy or aHSCT | CSL362 (anti-CD123) | Primary: AE and DLT Secondary: PK and ADA |
30 | NCT01632852 | Completed (mid 2015) |
| R/R AML R/R MDS Patients not eligible for curative therapy |
KHK2823 (anti-CD123) | Primary: AE Secondary: PK, ORR, OS, EFS, RFS, DFS, and ADA |
60 | NCT02181699 | Active, not recruiting (completed mid 2017) |
| R/R or de novo AML Patients not eligible for curative therapy |
HMA vs. HMA + JNJ-56022473 (talacotuzumab, CSL362, anti-CD123) | Primary: CRR, OS Secondary: ORR, DOR, CR, EFS, RFS, AE, ADA, QOL, and PK |
326 | NCT02472145 | Active, not recruiting (estimated completion mid 2018) |
| AML and MDS after HMA failure | JNJ-56022473 (talacotuzumab, CSL362, anti-CD123) | Primary: ORR Secondary: AE, OS, PFS, HI, QOL, and DOR |
43 | NCT02992860 | Suspended (estimated completion late 2018) |
| R/R AML | SGN-CD123A (anti-CD123, PBD ADC) | Primary: AE, LA, and DLT Secondary: PK, ADA, ORR, DFS, and OS |
102 | NCT02848248 | Recruiting (estimated completion mid 2019) |
| R/R AML R/R BPDCN High-risk MDS R/R CMML, R/R bc CML, R/R MPN Patients not eligible for curative therapy |
IMGN632 (anti-CD123, DGN549 ADC) | Primary: MTD Secondary: AE, ORR, PK, and ADA |
155 | NCT03386513 | Recruiting (estimated completion early 2021) |
ADA, anti-drug antibodies; ADC, antibody–drug conjugate; AE, adverse events; aHSCT, allogeneic hematopoietic stem cell transplantation; ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; APL, acute promyelocytic leukemia; bc, blast-crisis; BPDCN, blastic plasmacytoid dendritic cell neoplasm; CML, chronic myeloid leukemia; CMML, chronic myelomonocytic leukemia; CR, complete remission; CRR, complete response rate; DFS, disease-free survival; DLT, dose-limiting toxicity; DOR, duration of response; EFS, event-free survival; HI, hematological improvement; HMA, hypomethylating agents; LA, laboratory abnormalities; mAb, monoclonal antibody; MDS, myelodysplastic syndrome; MDS/MPN, myelodysplastic-myeloproliferative neoplasm; MPN, myeloproliferative neoplasm; MTD, maximum tolerated dose; ORR, overall response rate; OS, overall survival; PBD, pyrrolobenzodiazepine dimer; PFS, progression-free survival; PK, pharmacokinetics; QOL, quality of life; RFS, relapse-free survival; R/R, refractory/relapsed.
Data from http://ClinicalTrials.gov (Accessed: February 18, 2018).