Clinical features of patients treated with HA-1 TCR-T
| Participant . | Age, y . | Disease . | Cytogenetic/molecular . | HCT to first relapse, d . | HCT to TCR-T, d . | Disease stage . | Lymphodepletion (doses) . | TCR-T dose level . | CRS . | ICANS . | GVHD after TCR-T . | Other relevant AE (maximal grade) . | Disease outcome . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 27 | B-ALL | Ph-like RCSD1-ABL2 + complex | 987 | >1000 | 1. MRD– CR 2. MRD+ CR 3. MRD+ CR | 1. Fludarabine (3) 2. Fludarabine (3) 3. Fludarabine (3) | 1. DL1 2. DL2 3. DL2 | No | No | No | No | 1. Maintained CR 6 mo 2. Progressive disease 3. Progressive disease |
| 2 | 58 | AML | del 5, -7, other | 195 | 257 | MRD– CR | Fludarabine (3) | DL1 | No | No | No | Neutropenia (4)∗ | Progressive disease |
| 3 | 2 | T-ALL | t(8:14), biallelic loss of CDKN2A and CDKN2B | 71 | 1. 181 2. 236 3. 546 | 1. MRD+ CR 2. MRD+ CR 3. Relapse | 1. Fludarabine (2) 2. Nil 3. NECTAR | 1. DL1 2. DL2 3. DL2 | No | No | No | Neutropenia (4)†, fatigue (2)† | 1. Response with MRD 2. MRD– CR 3. Progressive disease |
| 4 | 64 | MDS-AML | -5, -7, complex | 134 | 177 | MRD+ CR | Fludarabine (2) | DL1 | No | No | Grade 2 stage 1 acute GI | Infection (3-5)∗,‡ | Progressive disease |
| 5 | 51 | AML | t(2:8) U2AF1, IDH1 | 381 | 1. 453 2. 557 | 1. MRD+ CR 2. MRD+ CR | 1. Fludarabine (3) 2. Nil | 1. DL2 2. DL2 | No | No | No | Fever (1)† d 0-1, self-resolving | Progressive disease |
| 6 | 62 | AML | Complex, TP53 | 83 | 161 | MRD+ CR | Fludarabine (1) | DL2 | No | No | No | Fever (1)† d 0-1, self-resolving, Neutropenia (3)∗ | Progressive disease |
| 7 | 23 | AUL | Complex | 184 after second HCT | 267 after second HCT | MRD− CRi | Fludarabine (3) | DL2 | No | No | No | Neutropenia∗ (4), infection-related fever (3) through day 3∗,§ | Progressive disease |
| 8 | 66 | MDS-EB1 | Complex, -7, TP53 | 84 | 1. 179 2. 589 | MRD− CRi | Fludarabine (2) | 1. DL3 2. DL2 | No | No | Grade 1 acute skin, subsequent mild chronic | Fever (2)† with rigors, transient nausea, d 0-1, self-resolving | Maintained CR >27 mo |
| 9 | 57 | AML | t(11:19), KMT2a | 30 | 204 | Refractory relapse (38% blasts) | Clofarabine and cytarabine | DL3 | No | No | No | Infusion reaction (4)† Neutropenia (4)∗ | CRi at 3 and 5 wk Relapse at 12 wk |
| Participant . | Age, y . | Disease . | Cytogenetic/molecular . | HCT to first relapse, d . | HCT to TCR-T, d . | Disease stage . | Lymphodepletion (doses) . | TCR-T dose level . | CRS . | ICANS . | GVHD after TCR-T . | Other relevant AE (maximal grade) . | Disease outcome . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 27 | B-ALL | Ph-like RCSD1-ABL2 + complex | 987 | >1000 | 1. MRD– CR 2. MRD+ CR 3. MRD+ CR | 1. Fludarabine (3) 2. Fludarabine (3) 3. Fludarabine (3) | 1. DL1 2. DL2 3. DL2 | No | No | No | No | 1. Maintained CR 6 mo 2. Progressive disease 3. Progressive disease |
| 2 | 58 | AML | del 5, -7, other | 195 | 257 | MRD– CR | Fludarabine (3) | DL1 | No | No | No | Neutropenia (4)∗ | Progressive disease |
| 3 | 2 | T-ALL | t(8:14), biallelic loss of CDKN2A and CDKN2B | 71 | 1. 181 2. 236 3. 546 | 1. MRD+ CR 2. MRD+ CR 3. Relapse | 1. Fludarabine (2) 2. Nil 3. NECTAR | 1. DL1 2. DL2 3. DL2 | No | No | No | Neutropenia (4)†, fatigue (2)† | 1. Response with MRD 2. MRD– CR 3. Progressive disease |
| 4 | 64 | MDS-AML | -5, -7, complex | 134 | 177 | MRD+ CR | Fludarabine (2) | DL1 | No | No | Grade 2 stage 1 acute GI | Infection (3-5)∗,‡ | Progressive disease |
| 5 | 51 | AML | t(2:8) U2AF1, IDH1 | 381 | 1. 453 2. 557 | 1. MRD+ CR 2. MRD+ CR | 1. Fludarabine (3) 2. Nil | 1. DL2 2. DL2 | No | No | No | Fever (1)† d 0-1, self-resolving | Progressive disease |
| 6 | 62 | AML | Complex, TP53 | 83 | 161 | MRD+ CR | Fludarabine (1) | DL2 | No | No | No | Fever (1)† d 0-1, self-resolving, Neutropenia (3)∗ | Progressive disease |
| 7 | 23 | AUL | Complex | 184 after second HCT | 267 after second HCT | MRD− CRi | Fludarabine (3) | DL2 | No | No | No | Neutropenia∗ (4), infection-related fever (3) through day 3∗,§ | Progressive disease |
| 8 | 66 | MDS-EB1 | Complex, -7, TP53 | 84 | 1. 179 2. 589 | MRD− CRi | Fludarabine (2) | 1. DL3 2. DL2 | No | No | Grade 1 acute skin, subsequent mild chronic | Fever (2)† with rigors, transient nausea, d 0-1, self-resolving | Maintained CR >27 mo |
| 9 | 57 | AML | t(11:19), KMT2a | 30 | 204 | Refractory relapse (38% blasts) | Clofarabine and cytarabine | DL3 | No | No | No | Infusion reaction (4)† Neutropenia (4)∗ | CRi at 3 and 5 wk Relapse at 12 wk |
AE, adverse events; AUL, acute undifferentiated leukemia; Cri, CR with incomplete hematologic recovery; EB, excess blasts; GI, gastrointestinal; NECTAR, nelarabine, etoposide, and cyclophosphamide; Ph, Philadelphia chromosome.
Unrelated to TCR T-cell infusion.
Possibly or probably related to TCR T-cell infusion. Note: Cytopenias were short-term and self-resolving unless they were caused by progressive leukemia.
Infection = environmentally-acquired, severe Legionella pneumonia ultimately led to death with multiorgan failure concurrent with progressive AML, not attributed to TCR T-cell infusion.
Infection = methicillin-susceptible Staphylococcus aureus pneumonia and septicemia.