Results of early clinical trials on bispecific antibodies for AML
| Clinical trial no. . | Target . | Construct design . | Dosing . | Safety . | Efficacy (CR/CRi) . | No. patients treated to date . | Enrollment stage . |
|---|---|---|---|---|---|---|---|
| NCT02520427 | CD33 | BiTE | 0.5-720 µg/day; 0-3 dose steps; 14-28 days CIV | CRS 67% (≥G3 13%) | 7/42 | 96 | Terminated |
| NCT03224819 | CD33 | HLE-BiTE | 0.05-72 µg per dose, 2 IV infusions in 14 days | CRS 50% (≥G3 13%) | 1/27 | 46 | Terminated |
| NCT03144245 | CD33 | TandAb | 0.5-300 µg/day; 14 days CIV; 28-day cycle | CRS NA (≥G3 0%) | 2/35 | 53 | Completed |
| NCT02152956 | CD123 | DART | RP2D: 500 ng/kg/day; 7 dose steps; 28 days CIV; then 4 days/week | CRS 50% (≥G3 7%) | 8/30 | 246 | Terminated |
| NCT02715011 | CD123 | DuoBody | 0.6-6 µg/kg Q2W IV; 0.15-4.8 µg/kg twice weekly IV; 2.4-4.8 µg/kg twice weekly SC; 0-4 dose steps | CRS 44% (≥G3 15%) | 0/62 | 62 | Completed |
| NCT02730312/ NCT05285813 | CD123 | XmAb | 1.7 µg/kg IV; 4 dose steps on days 1, 3, 5, and 8 followed by weekly administration | CRS 44% (≥G3 15%) | 5/51 | 106 | Dose finding completed/ phase 2 initiated |
| NCT05086315 | CD123 | Trifunctional NK cell engager | 10-3000 µg/kg/dose in cycle 1; 100-3000 µg/kg QW for the rest of induction cycles | CRS 9% (≥G3 n.r.), IRR 43% | 3/23 | 23 | Recruiting |
| NCT03038230 | CLL1 | Biclonics IgG format | 0.675-240 mg weekly after initial ramp-up dosing; 3-4 dose steps | CRS 36% (≥G3 9%) | 0/58 | 62 | Active, not recruiting |
| Clinical trial no. . | Target . | Construct design . | Dosing . | Safety . | Efficacy (CR/CRi) . | No. patients treated to date . | Enrollment stage . |
|---|---|---|---|---|---|---|---|
| NCT02520427 | CD33 | BiTE | 0.5-720 µg/day; 0-3 dose steps; 14-28 days CIV | CRS 67% (≥G3 13%) | 7/42 | 96 | Terminated |
| NCT03224819 | CD33 | HLE-BiTE | 0.05-72 µg per dose, 2 IV infusions in 14 days | CRS 50% (≥G3 13%) | 1/27 | 46 | Terminated |
| NCT03144245 | CD33 | TandAb | 0.5-300 µg/day; 14 days CIV; 28-day cycle | CRS NA (≥G3 0%) | 2/35 | 53 | Completed |
| NCT02152956 | CD123 | DART | RP2D: 500 ng/kg/day; 7 dose steps; 28 days CIV; then 4 days/week | CRS 50% (≥G3 7%) | 8/30 | 246 | Terminated |
| NCT02715011 | CD123 | DuoBody | 0.6-6 µg/kg Q2W IV; 0.15-4.8 µg/kg twice weekly IV; 2.4-4.8 µg/kg twice weekly SC; 0-4 dose steps | CRS 44% (≥G3 15%) | 0/62 | 62 | Completed |
| NCT02730312/ NCT05285813 | CD123 | XmAb | 1.7 µg/kg IV; 4 dose steps on days 1, 3, 5, and 8 followed by weekly administration | CRS 44% (≥G3 15%) | 5/51 | 106 | Dose finding completed/ phase 2 initiated |
| NCT05086315 | CD123 | Trifunctional NK cell engager | 10-3000 µg/kg/dose in cycle 1; 100-3000 µg/kg QW for the rest of induction cycles | CRS 9% (≥G3 n.r.), IRR 43% | 3/23 | 23 | Recruiting |
| NCT03038230 | CLL1 | Biclonics IgG format | 0.675-240 mg weekly after initial ramp-up dosing; 3-4 dose steps | CRS 36% (≥G3 9%) | 0/58 | 62 | Active, not recruiting |
IV, intravenous; IRR, infusion-related reaction; NA, not applicable; QW, once weekly; Q2W, once every 2 weeks; SC, subcutaneous injection; TandAb, tandem diabody.