Table 4.
Characteristics of patients that developed subsequent malignancies after genetically modified IECs
| Patient | Age at enrollment (y) | Sex | Primary disease | HSCT | IEC type | Subsequent neoplasm | Time from IEC therapy, mo |
Tissue transgene detection | RCR | Time to LFU, y |
Outcome at last follow-up |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 6 | M | Neuroblastoma | Yes (auto-HSCT) |
GD2 CAR T | AML | 1.5 | Negative | Negative | 3 | Alive |
| 2 | 27 | F | HL | Yes (auto-HSCT) |
DNR TGF-β EBVSTs | MDS | 24 | Negative | Negative | 3 | Died of complications after allogeneic transplant |
| 3 | 17 | M | Nasopharyngeal carcinoma | No | DNR TGF-β EBVSTs | Spindle-cell neoplasm | 24 | Negative | Negative | 4.5 | Alive |
| 4 | 62 | M | CLL | Yes (allo-HSCT) |
CD19 CAR T | Bladder cancer | 48 | Negative | Negative | 5 | Died of secondary infection |
| 5 | 11 | M | Glioblastoma | No | HER2 CAR T | T-cell lymphoma | 36 | Negative | Negative | 6 | Died of T-cell lymphoma |
| 6 | 60 | M | CLL | No | CD19 CAR T | BCCx2* | 36 and 48 | Unable to obtain | Negative | 6 | Alive |
| 7 | 47 | F | HL | Yes (auto-HSCT) |
DNR TGF-β EBVSTs | Breast ductal cell carcinoma | 42 | Negative | Negative | 7 | Alive |
| 8 | 55 | M | NHL | Yes (auto-HSCT) |
CD19 CAR T | BCC | 36 | Unable to obtain | Negative | 7.5 | Alive |
| 9 | 56 | M | NHL | No | CD19 and κ CAR T | 1-Penile squamous cell carcinoma | 72† | Negative | Negative | 7.5 | Died of MDS complications |
| 2-MDS | 36 | Negative | Negative | ||||||||
| 10 | 36 | M | HL | Yes (auto-HSCT) |
Auto EBVSTs with NeoR | 1-RCC | 154 | Unable to obtain | Negative | 15 | Alive |
| 2-Meningioma | 172 | Unable to obtain | Unable to obtain | ||||||||
| 11 | 18 | M | ALL and secondary AML | Yes (allo-HSCT) |
Allo EBVSTs with NeoR | Nerve sheath tumor‡ | 96 | Negative | Negative | 15 | Died of unrelated accident |
| 12 | 8 | M | AML | Yes (allo-HSCT) |
Allo EBVSTs with NeoR | Thyroid adenoma | 144 | Unable to obtain | Negative | 15 | Alive |
| 13 | 15 | F | ALL | Yes (allo-HSCT) |
Allo EBVSTs with NeoR | BCC | 156 | Negative | Negative | 15 | Alive |
ALL, acute lymphocytic leukemia; Allo, allogeneic; AML, acute myelocytic leukemia; auto, autologous; BCC, basal cell carcinoma; CLL, chronic lymphoid leukemia; LFU, last follow-up; MDS, myelodysplastic syndrome; NeoR, neomycin resistant marker gene; RCC, renal cell carcinoma; RCR, replication-competent retrovirus; TGF, transforming growth factor.
*
Patient was diagnosed with 2 basal cell carcinomas of the skin at 36 and 48 mo after infusion.
†
Patient received both CD-19 and κ CAR. Time to last follow-up and to secondary malignancy was calculated from time of his first infusion (CD19 CAR).
‡
Patient with history of neurofibromatosis.