Demographic and preinfusion clinical characteristics of included patients
| Characteristic . | Patient 1 . | Patient 2 . | Patient 3 . | Patient 4 . | Patient 5 . |
|---|---|---|---|---|---|
| Clinical history before infusion | |||||
| Age at infusion, y | 7 | 14 | 13 | 2.5 | 7 |
| Sex | F | M | M | M | M |
| Cancer genetics | T21 related | IGH::CRLF2 fusion, IZKF1 deletion | Hyperdiploid | KMT2A-R | TCF3 rearrangement, ETV6 deletion |
| No. of relapses | 3 | 2 | 1 | 1 | 1 |
| Prior CART products received | Tisacel (2 y prior), CART22-65s (1 y prior) | Tisacel (8 mo prior) | None | None | None |
| Prior blinatumomab | No | Yes (10 mo and >1 y prior) | No | No | Yes (4 mo prior) |
| Highest CNS status over course of previous treatment | 2 | 1 | 2 | 3 | 1 |
| History of cranial or craniospinal radiation | Yes | No | No | Yes (optic nerve) | No (XRT to mandibular mass) |
| History of previous ICANS | ICANS grade 4 (tisacel) | ICANS grade 3 (tisacel) | No | No | No |
| History of chronic neurologic disorder | None | None | None | CNS involvement of leukemia | Peripheral neuropathy (VCR) |
| Previous HSCT | Yes | No | No | Yes | No |
| Disease status before infusion | |||||
| Bone marrow blasts at infusion, % | 64 | 99 | 26 | 0 | 93 |
| CNS status based on CSF at CART infusion | 1 | N/A (LP deferred; CNS1 several weeks prior) | 1 | 1 | 1 |
| CART treatment information | |||||
| CART product | CART22-65s | CART22-65s | huCART19 | Tisacel | Investigational CTL019 |
| Lymphodepleting chemotherapy | Flu/Cy | Flu/Cy | Flu/Cy | Flu/Cy | Flu/Cy |
| Mortality | Yes | Yes | No | Yes | Yes |
| CNS status at day 28 after CAR infusion | 1 | 3 | 1 | 1 | 1 |
| Characteristic . | Patient 1 . | Patient 2 . | Patient 3 . | Patient 4 . | Patient 5 . |
|---|---|---|---|---|---|
| Clinical history before infusion | |||||
| Age at infusion, y | 7 | 14 | 13 | 2.5 | 7 |
| Sex | F | M | M | M | M |
| Cancer genetics | T21 related | IGH::CRLF2 fusion, IZKF1 deletion | Hyperdiploid | KMT2A-R | TCF3 rearrangement, ETV6 deletion |
| No. of relapses | 3 | 2 | 1 | 1 | 1 |
| Prior CART products received | Tisacel (2 y prior), CART22-65s (1 y prior) | Tisacel (8 mo prior) | None | None | None |
| Prior blinatumomab | No | Yes (10 mo and >1 y prior) | No | No | Yes (4 mo prior) |
| Highest CNS status over course of previous treatment | 2 | 1 | 2 | 3 | 1 |
| History of cranial or craniospinal radiation | Yes | No | No | Yes (optic nerve) | No (XRT to mandibular mass) |
| History of previous ICANS | ICANS grade 4 (tisacel) | ICANS grade 3 (tisacel) | No | No | No |
| History of chronic neurologic disorder | None | None | None | CNS involvement of leukemia | Peripheral neuropathy (VCR) |
| Previous HSCT | Yes | No | No | Yes | No |
| Disease status before infusion | |||||
| Bone marrow blasts at infusion, % | 64 | 99 | 26 | 0 | 93 |
| CNS status based on CSF at CART infusion | 1 | N/A (LP deferred; CNS1 several weeks prior) | 1 | 1 | 1 |
| CART treatment information | |||||
| CART product | CART22-65s | CART22-65s | huCART19 | Tisacel | Investigational CTL019 |
| Lymphodepleting chemotherapy | Flu/Cy | Flu/Cy | Flu/Cy | Flu/Cy | Flu/Cy |
| Mortality | Yes | Yes | No | Yes | Yes |
| CNS status at day 28 after CAR infusion | 1 | 3 | 1 | 1 | 1 |
Cy, cyclophosphamide; F, female; Flu, fludarabine; HSCT, hematopoietic stem cell transplant; M, male; N/A, not available; tisacel, tisagenlecleucel; VCR, vincristine; XRT, radiation therapy.