Table 1 Baseline characteristics of the patients
From: CD19 CAR-T cells for treatment-refractory autoimmune diseases: the phase 1/2 CASTLE basket trial
N | All | SLE | SSc | IIM |
|---|---|---|---|---|
24 | 10 | 9 | 5 | |
Demographic characteristics | ||||
Age (years), median (IQR) | 39 (26−53) | 31 (24−55) | 36 (27−56) | 44 (45−69) |
Sex (N female (%)) | 17 (71) | 7 (70) | 6 (67) | 4 (80) |
Disease-specific characteristics | ||||
Disease duration (years) | 4.0 (1.3−6.5) | 5.0 (2.5−9.0) | 2.5 (0.9−5.0) | 2.3 (0.9−9.3) |
Previous therapies (N), median (IQR) | 4.0 (3.0−6.0) | 5.5 (5.0−8.2) | 3.0 (2.5−4.0) | 2.0 (2.0−5.5) |
SLEDAI (U), median (IQR) | - | 11 (6.0−14.0) | - | - |
mRSS (U), median (IQR) | - | - | 26 (17−30.5) | - |
MMT-8 (U), median (IQR) | - | - | - | 117 [75.5−138] |
VAS global (mm), median (IQR) | 63 (53−75) | 62 (54−68) | 63 (58−76) | 51 (42−83) |
VAS physician (mm), median (IQR) | 68 (54−75) | 63 (56−73) | 74 (61−84) | 54 (45−65) |
FACIT (U), median (IQR) | 26 (13−48) | 19 (11−40) | 27 (11−48) | 34 (18−48) |
HAQ (U), median (IQR) | 1.1 (0.1−2.0) | 0.7 (0.1−1.4) | 1.1 (0.3−2.1) | 2.3 (0.4−2.6) |
Organ involvement | ||||
Major organs involved, N (%) | 4.0 (3.0−4.0) | 4.0 (4.0−5.0) | 4.0 (3.0−5.0) | 2.0 (2.0−4.0) |
Skin, N (%) | 22 (92%) | 10 (100%) | 9 (100%) | 3 (60%) |
Kidneys, N (%) | 8 (33%) | 8 (80%) | 0 (0%) | 0 (0%) |
Lungs, N (%) | 14 (58%) | 3 (30%) | 9 (100%) | 2 (40%) |
Heart, N (%) | 7 (29%) | 3 (30%) | 4 (44%) | 0 (0%) |
Muscle, N (%) | 9 (38%) | 0 (0%) | 4 (44%) | 5 (100%) |
Joints, N (%) | 11 (46%) | 7 (70%) | 2 (22%) | 2 (40%) |
Gastrointestinal, N (%) | 9 (38%) | 1 (10%) | 8 (89%) | 0 (0%) |
Hematology, N (%) | 4 (17%) | 4 (40%) | 0 (0%) | 0 (0%) |
Serositis, N (%) | 7 (29%) | 7 (70%) | 0 (0%) | 0 (0%) |
Laboratory parameters | ||||
WBC (cells/μl × 10−3), median (IQR) | 6.6 (4.5−9.0) | 4.6 (4.0−6.8) | 7.7 (6.7−10.0) | 6.3 (5.3−9.7) |
B cells (cells/μl), median (IQR) | 45 (3−130) | 43 (13−78) | 39 (4−136) | 50 (2−159) |
IgG (mg dl−1), median (IQR) | 1,051 (780−1,252) | 818 (701−1,218) | 1,069 (929−1,187) | 1,257 (813−1,312) |
IgA (mg dl−1), median (IQR) | 168 (127−271) | 168 (121−285) | 153 (131−206) | 212 (77−524) |
IgM (mg dl−1), median (IQR) | 80 (66−133) | 66 (45−85) | 120 (78−148) | 80 (47−143) |
CRP (mg l−1), median (IQR) | 5.8 (2.7−25.6) | 14.2 (4.5−27.6) | 6.2 (3.2−81.0) | 2.4 (0.7−4.2) |
IL-6 (pg ml−1), median (IQR) | 6.3 (3.6−10.7) | 8.4 (4.5−15.3) | 6.4 (3.5−44.1) | 3.7 (1.9−5.1) |
Ferritin (ng ml−1), median (IQR) | 141 (87−219) | 171 (114−500) | 147 (78−208) | 126 (63−201) |
