Table 7. Summary of lymphoma incidence in NSG mice administered with CART19.
| Organ with lymphoma | Lymphoma incidence* | |||
|---|---|---|---|---|
| Buffer | 0.2e+7 CART19 | 0.6e+7 CART19 | 1.8e+7 CART19 | |
| Liver | ||||
| 14 days after dosing | 2/2 | 5/5 | 5/6 | 1/3 |
| 28 days after dosing | – | 2/2 | 2/3 | 4/5 |
| Found dead | 17/22 | 15/16 | 12/15 | 9/13 |
| Spleen | ||||
| 14 days after dosing | 2/2 | 3/5 | 3/6 | 0/3 |
| 28 days after dosing | – | 1/2 | 0/3 | 3/5 |
| Found dead | 17/22 | 13/16 | 9/15 | 9/13 |
| Kidney | ||||
| 14 days after dosing | 2/2 | 3/5 | 5/6 | 1/3 |
| 28 days after dosing | – | 1/2 | 1/3 | 3/5 |
| Found dead | 14/22 | 14/16 | 11/15 | 9/13 |
| Lung | ||||
| 14 days after dosing | 2/2 | 4/5 | 0/6 | 1/3 |
| 28 days after dosing | – | 1/2 | 0/3 | 2/5 |
| Found dead | 17/22 | 11/16 | 8/15 | 6/13 |
| Heart (found dead) | 0/22 | 0/16 | 2/15 | 3/13 |
| Brain | ||||
| 14 days after dosing | 2/2 | 3/5 | 1/6 | 1/3 |
| 28 days after dosing | – | 2/2 | 1/3 | 2/5 |
| Found dead | 15/22 | 11/16 | 10/15 | 2/13 |
| Sternum with bone marrow | ||||
| 14 days after dosing | 2/2 | 5/5 | 2/6 | 1/3 |
| 28 days after dosing | – | 0/2 | 0/3 | 1/5 |
| Found dead | 17/22 | 14/16 | 10/15 | 9/13 |
| Pituitary (found dead) | 0/22 | 1/16 | 2/15 | 1/13 |
| Stomach (found dead) | 0/22 | 0/16 | 0/15 | 1/13 |
| Duodenum (found dead) | 0/22 | 1/16 | 0/15 | 0/13 |
| Jejunum (found dead) | 0/22 | 0/16 | 0/15 | 1/13 |
| Ileum (found dead) | – | 0/2 | 0/3 | 1/5 |
| Spine | ||||
| 28 days after dosing | – | 1/2 | 0/3 | 1/5 |
| Found dead | 0/22 | 3/16 | 3/15 | 3/13 |
| Testis (found dead) | 0/10 | 0/8 | 1/6 | 0/6 |
| Epididymis (found dead) | 0/10 | 1/8 | 1/6 | 0/6 |
| Prostate (found dead) | – | 0/1 | 1/3 | – |
| Uterus | ||||
| 14 days after dosing | – | 0/3 | 2/3 | 1/3 |
| 28 days after dosing | – | 1/1 | – | 1/2 |
| Found dead | 1/12 | 5/8 | 5/9 | 1/7 |
| Ovary | ||||
| 14 days after dosing | – | 2/3 | 1/3 | 1/3 |
| 28 days after dosing | – | 0/1 | – | 1/2 |
| Found dead | 3/12 | 6/8 | 6/9 | 1/7 |
*, total number of males and females with lymphomas in various tissues/organs/total number of males and females examined by macroscopy in each group. When the tissue autolysis was found in dead animal, the macroscopic findings wasn’t recorded. The incidence of lymphomas in all organs was recorded by histopathological examination on the day 14 and day 28 after administration, respectively. In addition, the lymphomas incidence of dead/moribund animals was listed separately for each group during the 56-day trial period. –: there were no animals to be executed as planned in the CAR-T cells dose group on the day 14/28 after administration. CAT-T, chimeric antigen receptor-modified T.