Table 5.
Clinical trials of mAbs that target the microenvironment in myeloid neoplasms.
| Disease type and inclusion criteria | Drug or drug combination, other therapies | Outcome measures | (Estimated) enrollment | Clinical trials identifier | Trial status |
|---|---|---|---|---|---|
| Newly diagnosed AML (in patients not eligible for curative therapy) | Ulocuplumab (anti-CXCR4; BMS-936564, MDX-1338) + low-dose cytarabine | Primary: DLT, AE, SAE, CR, and CRi Secondary: OR, PK, and OS |
126 | NCT02305563 | Recruiting (estimated completion late 2021) |
| R/R AML | PF-06747143 (anti-CXCR4) single agent or combination with standard chemotherapy | Primary: DLT, ORR, and PFS Secondary: AE, PK, and DOR |
8 | NCT02954653 | Terminated (late 2017) |
| R/R AML Secondary AML FL, DLBCL, and CLL |
Ulocuplumab (anti-CXCR4; BMS-936564, MDX-1338) + chemotherapy | Primary: DLT, AE, and SAE Secondary: OR and PK |
96 | NCT01120457 | Completed (late 2014) |
| R/R AML | IGN523 (anti-CD98) monotherapy | Primary: DLT, AE, and SAE Secondary: OR, PK, and ADA |
19 | NCT02040506 | Completed (mid 2015) |
| AML, relapsed after aHSCT | F16-IL2 (anti-tenascin C IL-2 fusion protein) + low-dose cytarabine | Primary: DLT Secondary: ORR, RFS, CR, CRi, PFS, OS, GvHD, chimerism, and ADA |
30 | NCT02957032 | Recruiting (estimated completion early 2017) |
| AML, relapsed after aHSCT | F16-IL2 + BI 836858 (anti-CD33) | Primary: DLT, MTD Secondary: ORR, RFS, CR, CRi, PFS, OS, GvHD, PK, and ADA |
52 | NCT03207191 | Recruiting (estimated completion mid 2019) |
ADA, anti-drug antibodies; AE, adverse events; aHSCT, allogeneic hematopoietic stem cell transplantation; AML, acute myeloid leukemia; CLL, chronic lymphocytic leukemia; CR, complete remission; CRi, complete remission with incomplete recovery; DLBCL, diffuse large B cell lymphoma; DLT, dose-limiting toxicity; FL, follicular lymphoma; GvHD, graft-versus-host disease; IL, interleukin; mAb, monoclonal antibody; MTD, maximum tolerated dose; OR, objective response; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; RFS, relapse-free survival; R/R, refractory/relapsed; SAE, serious adverse events.
Data from http://ClinicalTrials.gov (Accessed: February 21, 2018).