Table 7.
Active clinical trials of bispecific antibodies in myeloid neoplasms.
| Disease type and inclusion criteria | Drug or drug combination, other therapies | Outcome measures | (Estimated) enrollment | Clinical trials identifier | Trial status |
|---|---|---|---|---|---|
| ALL, AML, myeloid sarcoma, CML, JMML, MDS, NHL CD19-positive R/R after first aHSCT ≤21 years old Suitable aHSCT donor available |
Blinatumomab + ATG + cyclophosphamide + fludarabine + G-CSF + melphalan + mesna + rituximab (anti-CD20) + tacrolimus/sirolimus + thiotepa + aHSCT + T cell infusion | Primary: engraftment at 30 days Secondary: blinatumomab toxicity, CIR, GvHD, and transplant-related mortality |
18 | NCT02790515 | Recruiting (estimated completion mid 2020) |
| R/R AML | AMG330 (CD3/CD33; classical BiTE) | Primary: DLT and AE Secondary: BP, PK, and ORR |
50 | NCT02520427 | Recruiting (estimated completion mid 2018) |
| AML bc CML BPDCN B-ALL |
XmAb14045 (CD3/CD123; modified Fc-containing BiTE) | Primary: safety, MTD, and toxicity | 66 | NCT02730312 | Recruiting (estimated completion mid 2019) |
| R/R AML | JNJ-63709178 (CD3/CD123; modified Fc-containing BiTE) | Primary: DLT and AE Secondary: BP and ORR |
60 | NCT02715011 | Recruiting (estimated completion late 2020) |
| R/R AML | MCLA-117 (CD3/CLEC12A; modified Fc-containing BiTE) | Primary: DLT Secondary: BP, PK, and OR |
50 | NCT03038230 | Recruiting (estimated completion late 2018) |
| R/R AML High-risk MDS |
MGD006 (CD3/CD123; DART) | Primary: DLT Secondary: AE, SAE, and PK |
124 | NCT02152956 | Recruiting (estimated completion early 2018) |
AE, adverse events; ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; ATG, anti-thymocyte globulin; B-ALL, B cell acute lymphoblastic leukemia; bc, blast-crisis; BP, blood parameters; BPDCN, blastic plasmacytoid dendritic cell neoplasm; CIR, cumulative incidence of relapse; CLEC12A, C-type lectin domain family 12 member A; CML, chronic myeloid leukemia; DART, dual affinity retargeting; DLT, dose-limiting toxicity; G-CSF, granulocyte colony-stimulating factor; JMML, juvenile myelomonocytic leukemia; MDS, myelodysplastic syndrome; MTD, maximum tolerated dose; NHL, non-Hodgkin lymphoma; OR, objective response; ORR, overall response rate; PK, pharmacokinetics; R/R, refractory/relapsed; SAE, serious adverse events.
Data from http://ClinicalTrials.gov (Accessed: February 06, 2018).