Potential exclusion from anti-CD20 bispecific antibodies clinical trials
| Clinical trials . | Clinical trial exclusion criteria and number of patients potentially excluded (N = 75) . | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Exclusion criteria . | Total N (%) . | ||||||||
| Hb, g/dL . | ANC, 109/L . | Plt, 109/L . | Any hematologic exclusion criteria . | Renal function . | Liver function . | ECOG . | CNS disease . | ||
| Glofitamab7 | <10.0 | <1.5 | <75 | 47 (63%) | GFR < 50 mL/min | T. Bili > 1.5 × ULN‡, ALT/AST > 3.0 × ULN‡ | >1 | Yes | 53 (71%) |
| Excluded N (%) | 36 (48%) | 32 (43%) | 30 (40%) | 8 (11%) | 5 (7%) | 14 (22%) | 8 (11%) | ||
| Odronextamab8 | <9.0∗ | <1.0∗ | <75∗ | 40 (53%) | GFR < 50 mL/min | T. Bili > 1.5 × ULN‡, ALT/AST > 2.5 × ULN‡ | >1 | Yes | 48 (64%) |
| Excluded N (%) | 23 (31%) | 19 (25%) | 30 (40%) | 8 (11%) | 6 (8%) | 14 (22%) | 8 (11%) | ||
| Epcoritamab9 | None | <1.0† | <75† | 36 (48%) | GFR < 45 mL/min | T. Bili > 1.5 × ULN‡, ALT/AST > 3.0 × ULN‡ | >2 | Yes | 39 (52%) |
| Excluded N (%) | 0 | 19 (25%) | 30 (40%) | 5 (7%) | 5 (7%) | 3 (5%) | 8 (11%) | ||
| Plamotamab10 | None | <1.0 | <50 | 28 (37%) | GFR < 40 mL/min | T. Bili > 1.5 mg/dL ALT/AST > 3.0 × ULN‡ | >2 | Yes | 33 (44%) |
| Excluded N (%) | 0 | 19 (25%) | 21 (28%) | 3 (4%) | 5 (7%) | 3 (5%) | 8 (11%) | ||
| Excluded from all the above trials N (%)§ | 0 | 19 (25%) | 21 (28%) | 28 (37%) | 3 (4%) | 5 (7%) | 3 (5%) | 8 (11%) | 33 (44%) |
| Clinical trials . | Clinical trial exclusion criteria and number of patients potentially excluded (N = 75) . | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Exclusion criteria . | Total N (%) . | ||||||||
| Hb, g/dL . | ANC, 109/L . | Plt, 109/L . | Any hematologic exclusion criteria . | Renal function . | Liver function . | ECOG . | CNS disease . | ||
| Glofitamab7 | <10.0 | <1.5 | <75 | 47 (63%) | GFR < 50 mL/min | T. Bili > 1.5 × ULN‡, ALT/AST > 3.0 × ULN‡ | >1 | Yes | 53 (71%) |
| Excluded N (%) | 36 (48%) | 32 (43%) | 30 (40%) | 8 (11%) | 5 (7%) | 14 (22%) | 8 (11%) | ||
| Odronextamab8 | <9.0∗ | <1.0∗ | <75∗ | 40 (53%) | GFR < 50 mL/min | T. Bili > 1.5 × ULN‡, ALT/AST > 2.5 × ULN‡ | >1 | Yes | 48 (64%) |
| Excluded N (%) | 23 (31%) | 19 (25%) | 30 (40%) | 8 (11%) | 6 (8%) | 14 (22%) | 8 (11%) | ||
| Epcoritamab9 | None | <1.0† | <75† | 36 (48%) | GFR < 45 mL/min | T. Bili > 1.5 × ULN‡, ALT/AST > 3.0 × ULN‡ | >2 | Yes | 39 (52%) |
| Excluded N (%) | 0 | 19 (25%) | 30 (40%) | 5 (7%) | 5 (7%) | 3 (5%) | 8 (11%) | ||
| Plamotamab10 | None | <1.0 | <50 | 28 (37%) | GFR < 40 mL/min | T. Bili > 1.5 mg/dL ALT/AST > 3.0 × ULN‡ | >2 | Yes | 33 (44%) |
| Excluded N (%) | 0 | 19 (25%) | 21 (28%) | 3 (4%) | 5 (7%) | 3 (5%) | 8 (11%) | ||
| Excluded from all the above trials N (%)§ | 0 | 19 (25%) | 21 (28%) | 28 (37%) | 3 (4%) | 5 (7%) | 3 (5%) | 8 (11%) | 33 (44%) |
Table depicting the exclusion criteria for each of the clinical trials (anti-CD20 bispecific antibodies) and number of patients who would be excluded based on each of these criteria and total excluded for each trial.
Abbreviations are explained in Table 1.
If because of BM or splenic involvement, exclusion criteria would be Hb < 7.0, ANC < 500, and Plt < 25 000.
Growth factors use allowed if because of BM involvement.
T. Bili ULN, 1.2 mg/dL; ALT ULN, 55 U/L; AST ULN, 48 U/L.
Last row shows number of patients who would be excluded from all the trials based on each and combined criteria.