Table 1.
Clinical study patient characteristics (n = 21).
| Pt | Sex | Age | Disease | Cyto genetics | Chemotherapy cycles | Pretreatment Regimen | BM Blast pre-lymphodepletion (%) | GC007F cell dose | CAR+ (%) | CRS | ICANS | CR |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | F | 39 | Ph+ B-ALL | T315I/V299L | 5 | VDLP + TKI×2, CAM×1 HyperCVAD (Part B) + TKI × 2 | 0.71 | DL1 | 31.8 | 1 | No | MRD- |
| 2 | F | 14 | Ph- B-ALL | Normal | 3 | VDLP × 1, CAM × 1 HyperCVAD (Part B) × 1 | 0.05 | DL1 | 33.30 | No | No | MRD- |
| 3 | F | 27 | Ph- B-ALL | Normal | 4 | CVDLP × 2 HyperCVAD (Part B) × 2 | 87.87 | DL1 | 32 | 3 | No | MRD- |
| 4 | F | 27 | Ph+ B-ALL | CALR, T315I | 5 | VDLP + TKI×3 CAM + TKI×1 HyperCVAD (Part B) + TKI × 1 | 85.47 | DL2 | 40.1 | 2 | No | MRD+ |
| 5 | M | 25 | Ph+ B-ALL | BCR/ABL | 3 | CVDLP + TKI × 2 HyperCVAD (Part B) + TKI × 1 Allogeneic transplant | 47.86 | DL2 | 15.1 | 3 | No | MRD- |
| 6 | F | 21 | Ph- B-ALL | Normal | 4 | VDLP × 2 HyperCVAD (Part B) × 2 | 0.05 | DL2 | 19.1 | 3 | No | MRD- |
| 7 | M | 15 | Ph+ B-ALL | BCR/ABL | 5 | VDLP + TKI × 2 CAM + TKI × 1 HyperCVAD (Part B) + TKI × 2 | 0.45 | DL2 | 46.1 | 3 | No | MRD- |
| 8 | M | 15 | Ph- B-ALL | Normal | 3 | VDLP × 1 HyperCVAD (Part B) × 2 | 7.27 | DL2 | 33.7 | 3 | 3 | MRD- |
| 9 | M | 24 | Ph- B-ALL | TEL/AML | 5 | CVDLP × 3 HyperCVAD (Part B) × 2 | 94.01 | DL2 | 42 | 2 | 3 | MRD- |
| 10 | F | 61 | Ph- B-ALL | IKZF1,SH2B3 | 5 | VDLP + TKI × 3 HyperCVAD (Part B) + TKI × 2 | 0.01 | DL2 | 26.1 | 2 | No | MRD- |
| 11 | M | 47 | Ph- B-ALL | Normal | 2 | CVDLP × 1, CAM × 1 | 59.74 | DL2 | 42.2 | 2 | No | MRD- |
| 12 | F | 41 | Ph- B-ALL | Normal | 2 | VDLP × 2 | 57.14 | DL2 | 39.5 | 3 | No | MRD- |
| 13 | M | 17 | Ph- B-ALL | Normal | 7 | VDLP × 4, CAM × 2 HyperCVAD (Part B) × 1 | 17.86 | DL3 | 46.9 | 3 | 2 | MRD- |
| 14 | F | 18 | Ph- B-ALL | E2A-PBX1 | 5 | VDLP × 2, CAM × 1 HyperCVAD (Part B) × 2 Allogeneic transplant | 1.77 | DL3 | 50.9 | 3 | 1 | MRD- |
| 15 | M | 32 | Ph- B-ALL | Normal | 5 | CVDLP × 2, CAM × 1 HyperCVAD (Part B) × 2 | 69 | DL3 | 46 | 2 | No | MRD- |
| 16 | F | 14 | Ph- B-ALL | WTI | 5 | CVILP × 2, CAM × 1 HyperCVAD (Part B) × 2 | 1.67 | DL3 | 40.1 | 3 | 3 | MRD- |
| 17 | F | 44 | Ph- B-ALL | Normal | 5 | CVILP × 2, CAM × 1 HyperCVAD (Part B) × 2 Allogeneic transplant | 38.5 | DL3 | 60.4 | 2 | No | MRD- |
| 18 | M | 47 | Ph- B-ALL | Normal | 9 | CVDLP × 2, CAM × 1 HyperCVAD (Part B) × 2, et al. | 85.29 | DL3 | 39.4 | 3 | No | MRD- |
| 19 | F | 32 | Ph- ALL | MLL-AF4 | 2 | VDLP × 1 HyperCVAD (Part B) × 1 | 87.31 | DL2 | 26.8 | 2 | 2 | NE |
| 20 | M | 44 | Ph- ALL | Normal | 5 | CVDLP × 2, CAM × 1 HyperCVAD (Part B) × 2 | 62 | DL2 | 21.3 | 4 | No | NE |
| 21 | M | 45 | Ph- ALL | Normal | 25 | CVDLP × 3, CAM × 1, HyperCVAD (Part B) × 2, et al. | 92.3 | DL3 | 43.3 | 3 | No | NE |
Pt Patient, CAR-T cell chimeric antigen receptor T cell, CRS cytokine release syndrome, ICANS immune effector cell-associated neurotoxicity syndrome, CR complete remission, MRD minimum residual disease, Ph+-B-ALL Philadelphia chromosome positive acute lymphoblastic leukemia, Ph--B-ALL Philadelphia chromosome negative acute lymphoblastic leukemia, BM bone marrow, VDLP vincristine, daunorubicin, L-asparaginase and prednisone, TKI Tyrosine Kinase Inhibitor, HyperCVAD (Part B): dexamethasone, methotrexate and cytarabine, CAM cyclophosphamide, cytarabine, 6-mercaptopurine, CVDLP cyclophosphamide, vincristine, daunorubicin, L-asparaginase and prednisone, CVILP cyclophosphamide, vincristine, idarubicin, L-asparaginase and prednisone, NE Not evaluable.