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On 14 June 2019, at the 24th European Hematology Association Congress, Tanya Siddiqi presented results of the ongoing phase I/II TRANSCEND CLL 004 study. The study assessed the safety, pharmacokinetics and efficacy of lisocabtagene maraleucel (liso-cel, JCAR017). Liso-cel is an anti-CD19 chimeric antigen receptor (CAR) T-cell product administered as a defined composition of CD4+/CD8+ CAR T-cells.
The primary objectives of the study were safety and determination of the recommended phase II dose.
Baseline characteristics |
All patients (n = 23) |
DL1 (n = 9) |
DL2 (n = 14) |
---|---|---|---|
Received bridging therapy |
17 (73.9%) |
5 (55.6%) |
12 (85.7%) |
High-risk features |
19 (82.6%) |
6 (66.7%) |
13 (92.9%) |
Del (17p) |
8 (34.8%) |
3 (33.3%) |
5 (35.7%) |
Tp53 mutation |
14 (60.9%) |
4 (44.4%) |
10 (71.4%) |
Complex karyotypeb |
11 (47.8%) |
5 (55.6%) |
6 (42.9%) |
Previous therapy |
5 (2 – 11) |
5 (3 – 8) |
5 (2 – 11) |
Prior ibrutinib |
23 (100%) |
9 (100%) |
14 (100%) |
Ibrutinib relapsed/refractory |
21 (91.3%) |
9 (100%) |
12 (85.7%) |
Ibrutinib progression and prior venetoclax |
13 (56.5%) |
5 (55.6%) |
8 (57.1%) |
Dr Siddiqi mentioned how toxicities related to liso-cell were manageable, with promising clinical activity in patients who had been heavily pre-treated with ibrutinib and venetoclax. At both dose levels, adverse events were manageable, with a follow-up of 9 months showing a high proportion of durable responses that improved over time. The majority of responses and undetected MRD were achieved by day 30, with a large proportion of patients remaining in CR at 6 months, remaining in CR.
A phase II study is currently enrolling patients at dose level 2, stemming from the results of this phase I trial. Patients in this trial will be treated with liso-cel in combination with ibrutinib.
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