Table 1 Baseline characteristics of all patients and patients with GC who received CT041
From: Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial interim results
All patient characteristics | Dose-escalation/de-escalation n = 18 | Dose-expansion n = 22 | Total n = 37 |
|---|---|---|---|
Median age (range), years | 56.0 (38–74) | 43.5 (25–73) | 53.0 (25–74) |
Male sex, n (%) | 11 (73.3) | 13 (59.1) | 24 (64.9) |
Disease type, n (%) | |||
GC/GEJ | 12 (80) | 16 (72.7) | 28 (75.7) |
PC | 2 (13.3) | 3 (13.6) | 5 (13.5) |
Other GI | 1 (6.7) | 3 (13.6) | 4 (10.8) |
Median time since metastases (range), years | 1.20 (0.1–1.9) | 1.00 (0.2–3.2) | 1.00 (0.1–3.2) |
Peritoneal metastases, n (%) | 11 (73.3) | 12 (54.5) | 23 (62.2) |
ECOG score, n (%) | |||
0 | 2 (13.3) | 0 | 2 (5.4) |
1 | 13 (86.7) | 22 (100) | 35 (94.6) |
Bridging therapy, n (%) | 12 (80.0) | 16 (72.7) | 28 (75.7) |
CLDN18.2 expression, n (%)a | |||
Low expression | 0 | 5 (22.7) | 5 (13.5) |
Medium expression | 8 (53.3) | 5 (22.7) | 13 (35.1) |
High expression | 7 (46.7) | 12 (54.5) | 19 (51.4) |
Surgery | 9 (60.0) | 18 (81.8) | 27 (73.0) |
Median no. of previous lines, n (%) | 2 | 2 | 2 |
1 | 3 (20.0) | 3 (13.6) | 6 (16.2) |
2 | 9 (60.0) | 10 (45.5) | 19 (51.4) |
≥3 | 3 (20.0) | 9 (40.9) | 12 (32.4) |
Previous systemic therapies, n (%) | |||
Fluorouracil/analogs and derivatives | 15 (100) | 22 (100) | 37 (100) |
Taxanes | 12 (80.0) | 15 (68.2) | 27 (73.0) |
Platinum | 13 (86.7) | 19 (86.4) | 32 (86.5) |
Anti-PD-1/PD-L1 antibody | 6 (40.0) | 7 (31.8) | 13 (35.1) |
Polykinase inhibitor b | 4 (26.7) | 7 (31.8) | 11 (29.7) |
GC/GEJ patient characteristics | Dose escalation/de-escalation n = 12 | Dose-expansion n = 16 | Total n = 28 |
|---|---|---|---|
Histological (Lauren) classification, n (%) | |||
Intestinal type | 6 (50) | 4 (25.0) | 10 (35.7) |
Diffuse type | 3 (25) | 6 (37.5) | 9 (32.1) |
Mixed type | 2 (16.7) | 5 (31.3) | 7 (25.0) |
Unknown | 1 (8.3) | 1 (6.3) | 2 (7.1) |
Histological (WHO) classification, n (%) | |||
Mucinous adenocarcinoma | 0 | 1 (6.3) | 1 (3.6) |
Signet-ring cell carcinoma | 3 (25) | 9 (56.3) | 12 (42.9) |
Other | 9 (75) | 5 (31.3) | 14 (50.0) |
HER2 status, n (%) | |||
Negative | 11 (91.7) | 16 (100) | 27 (96.4) |
Positive | 0 | 0 | 0 |
Unknown | 0 | 1 (20) | 1 (3.6) |
Numbers of metastatic organs, n (%) | |||
≤2 | 5 (41.7) | 9 (56.3) | 14 (50.0) |
≥3 | 7 (58.3) | 7 (43.8) | 14 (50.0) |
Peritoneal metastases, n (%) | 9 (95.0) | 10 (62.5) | 19 (67.9) |
Median no. of previous lines, n (%) | |||
1 | 2 (16.7) | 3 (18.8) | 5 (17.9) |
2 | 7 (58.3) | 8 (50.0) | 15 (53.6) |
≥3 | 3 (25.0) | 5 (31.3) | 8 (28.6) |
Previous systemic therapies, n (%) | |||
Fluorouracil/analogs and derivatives | 12 (100) | 16 (100) | 28 (100) |
Taxanes | 10 (83.3) | 11 (68.8) | 21 (75.0) |
Platinum | 12 (100) | 15 (93.8) | 27 (96.4) |
Anti-PD-1/PD-L1 antibody | 6 (50.0) | 6 (37.5) | 12 (42.9) |
Polykinase inhibitor b | 4 (33.3) | 6 (37.5) | 10 (35.7) |
