Table 1.
Baseline characteristics of patients.
| All (n = 21) | Dose A (n = 12) | Dose B (n = 3) | Dose C (n = 3) | Doses under expectationa (n = 3) | |
|---|---|---|---|---|---|
| Age | |||||
| Median (IQR)—yr | 56 (46–62) | 64.5 (53–70) | 36 (36–46) | 57 (45.5–62.5) | 44 (43.5–45) |
| ≥65 yr—No. (%) | 3 (14) | 2 (17) | 0 (0) | 1 (33) | 0 (0) |
| Male sex—No. (%) | 11 (52) | 6 (50) | 2 (67) | 1 (33) | 2 (67) |
| Female sex—No. (%) | 10 (48) | 6 (50) | 1 (33) | 2 (67) | 1 (33) |
| Disease—No. (%) | |||||
| DLBCL | 17 (81) | 10 (83) | 2 (67) | 3 (100) | 2 (67) |
| MCL | 2 (10) | 1 (8) | 1 (33) | 0 (0) | 0 (0) |
| B-LBL | 1 (5) | 0 (0) | 0 (0) | 0 (0) | 1 (33) |
| FL | 1 (5) | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Disease stageb—No. (%) | |||||
| II | 2 (10) | 0 (0) | 1 (33) | 1 (33) | 0 (0) |
| III | 4 (19) | 4 (33) | 0 (0) | 0 (0) | 0 (0) |
| IV | 15 (71) | 8 (67) | 2 (67) | 2 (67) | 3 (100) |
| Risk stratificationc—No. (%) | |||||
| Worse than intermediate | 17 (81) | 11 (92) | 2 (67) | 2 (67) | 2 (67) |
| Intermediate or better | 4 (19) | 1 (8) | 1 (33) | 1 (33) | 1 (33) |
| ≥50% PD-L1 expressiond | 4 (19) | 2 (17) | 0 (0) | 1 (33) | 1 (33) |
| Prior therapies—No. (%) | |||||
| ≥3 prior lines of therapy | 18 (86) | 10 (83) | 3 (100) | 2 (67) | 3 (100) |
| Previous PD-1/PD-L1 mAb | 2 (10) | 1 (8) | 0 (0) | 0 (0) | 1 (33) |
| Previous auto-HSCT | 2 (10) | 1 (8) | 0 (0) | 0 (0) | 1 (33) |
| Bridging therapies applied | 10 (48) | 4 (33) | 3 (100) | 2 (67) | 1 (33) |
Abbreviations: IQR, interquartile range; yr., year(s); DLBCL, diffuse large B cell lymphoma; MCL, mantle cell lymphoma; B-LBL, B-lymphoblastic lymphoma; FL, follicular lymphoma; PCNS DLBCL, primary central nervous system DLBCL; PD-L1, programmed death-ligand 1; PD-1, programmed cell death protein 1; mAb, monoclonal antibody; auto-HSCT, autologous haematopoietic stem cell transplantation; IPI, international prognostic index; aaIPI, age-adjusted IPI; MIPI, mantle cell lymphoma IPI; FLIPI, follicular lymphoma IPI; NCCN, National Comprehensive Cancer Network; ALL, acute lymphoblastic leukemia.
These patients received doses other than pre-specified three dose levels because of unexpected low CAR percentages caused by the early and premature manufacturing process.
Staged as per Ann-Arbor Staging System pre-treatment.
Stratified as per IPI, aaIPI, MIPI, FLIPI score, or NCCN guideline for ALL pre-treatment.
4 patients had no available pre-treatment specimen.