Table 2.
Selected clinical studies with BsAbs for hematological malignancies
| Type/phase | Disease | Age | N | Comment | Reference |
|---|---|---|---|---|---|
| Blinatumomab for CD19+ lymphoma | |||||
| 1/2 | FL, MCL, DLBCL | Adults | 76 | At target dose (n = 35): 37% CR/Crh, 31% PR; median response duration, 13.5 mo | 1, 54 |
| 2 | DLBCL | Adults | 25 | 43% ORR (19% CR); median response duration, 11.6 mo | 55 |
| Blinatumomab for CD19+ leukemia | |||||
| 2 | ALL (Ph−) | Adults | 189 | 43% CR/CRh; median RFS, 5.9 mo; median OS, 6.9 mo | 2, 56 |
| 3 | ALL | Adults | 405 | Blinatumomab (n = 271): 44% CR/CRh; median RFS, 7.3 mo; median OS, 7.7 mo; chemotherapy (n = 134): 15% CR/CRh; median RFS, 4.6 mo; median OS, 4.0 mo | 3 |
| 1/2 | ALL | Children | 85 | At target dose (n = 70); 39% CR; median RFS, 4.4 mo; median OS, 7.5 mo | 58 |
| FBTA05 for CD20+ lymphoma/leukemia | |||||
| n/a | CLL, NHL, ALL | Adults | 9 | Compassionate use post–allogeneic HSCT in combination with DLI; transient clinical responses in 4/9 patients | 39, 64 |
| 1/2 | NHL, BL, ALL | Children | 10 | Pre/post–allogeneic HSCT; 3 SD, 1 PR, 5 maintained or sustained CR | 40 |
| CD20Bi for CD20+ lymphoma or MM | |||||
| 1 | DLBCL, FL | Adults | 15 | Pre/post–autologous HSCT: ATCs were mixed with BsAbs before infusion to generate BATs; safe; clinical impact difficult to assess | 66, 67 |
| 1 | MM | Adults | 12 | Pre/post–autologous HSCT: BATs; safe; clinical impact difficult to assess | 68 |
| CD123 DART for CD123+ AML/MDS | |||||
| 1 | AML, MDS | Adults | n/a | MGD006; recruiting participants (NCT02152956) | n/a |
| CD123 duobody for CD123+ AML | |||||
| 1 | AML | Adults | n/a | JNJ-63709178 (NCT02715011); on hold due to toxicity | n/a |
| CD33 BITE for CD33+ AML | |||||
| 1 | AML | Adults | n/a | AMG 330; was on temporary hold due to toxicity, currently recruiting participants (NCT02520427) | n/a |
ALL, acute lymphoblastic leukemia; ATCs, activated T cells; BAT, BsAb-armed T cells; CR, complete response; CRh, complete response with partial hematological recovery; DLBCL, diffuse large B-cell lymphoma; DLI, donor lymphocyte infusion; EFS: event-free survival; FL, follicular lymphoma; HSCT, hematopoietic stem cell transplantation; MCL, mantle cell lymphoma; MDS, myelodysplastic syndrome; MM, multiple myeloma; n/a, not available; NHL, non-Hodgkin lymphoma; ORR, overall response rate; OS, overall survival; PR, partial response; RFS, relapse-free survival; SD, stable disease.