Table 2.
Classification and characteristics of clinical trials on cell therapy worldwide.
| Items | Type | CAR n (%) | TCR n (%) | Stem n (%) | Vaccine n (%) | Other n (%) | Total n (%) |
|---|---|---|---|---|---|---|---|
| Phase | I | 78 (69.6) | 44 (50.6) | 8 (47.1) | 49 (26.1) | 49 (29.2) | 228 (39.9) |
| I/II | 30 (26.8) | 28 (32.2) | 4 (23.5) | 46 (24.5) | 34 (20.2) | 142 (24.8) | |
| II | 3 (2.7) | 14 (16.1) | 5 (29.4) | 76 (40.4) | 80 (47.6) | 178 (31.1) | |
| III/IV/other | 1 (0.9) | 1 (1.1) | 0 | 17 (9.0) | 5 (3) | 24 (4.2) | |
| Trial status | Open | 71 (63.4) | 37 (42.5) | 11 (64.7) | 38 (20.2) | 58 (34.5) | 215 (37.6) |
| Closed | 18 (16.1) | 26 (29.9) | 4 (23.5) | 57 (30.3) | 54 (32.1) | 159 (27.8) | |
| Completed | 23 (20.5) | 24 (27.6) | 2 (11.8) | 93 (49.5) | 56 (33.3) | 198 (34.6) | |
| Totally (n/572*%) | 112 (19.6) | 87 (15.2) | 17 (3.0) | 188 (32.8) | 168 (29.4) | 572 (100) | |
| Primary endpoint | Safety | 96 (85.7) | 66 (75.9) | 13 (76.5) | 98 (52.1) | 87 (51.8) | 360 (62.9) |
| Efficacy | 16 (14.3) | 21 (24.1) | 4 (23.5) | 90 (47.9) | 81 (48.2) | 212 (37.1) | |
| Patient population | Biomarker selected | 30 (26.8) | 36 (41.4) | 0 | 12 (6.4) | 18 (10.7) | 96 (16.8) |
| Unselected | 82 (73.2) | 51 (58.6) | 17 (100) | 176 (93.6) | 150 (89.3) | 476 (83.2) | |
| Area | China | 60 (53.6) | 20 (23.0) | 2 (11.8) | 6 (3.2) | 52 (31.0) | 140 (24.5) |
| USA | 42 (37.5) | 57 (65.5) | 9 (52.9) | 116 (61.7) | 55 (32.7) | 279 (48.8) | |
| Europe | 6 (5.4) | 2 (2.3) | 3 (17.6) | 39 (20.7) | 21 (12.5) | 71 (12.4) | |
| Other | 4 (3.6) | 8 (9.2) | 3 (17.6) | 27 (14.4) | 40 (23.8) | 82 (14.3) | |
| Therapy method | Neoadjuvant | 3 (2.7) | 2 (2.3) | 0 | 15 (8.0) | 3 (1.8) | 23 (4.0) |
| Adjuvant | 6 (5.4) | 5 (5.7) | 0 | 42 (22.3) | 18 (10.7) | 71 (12.4) |
NA, not applicable/available.