TRANSCEND CLL 004
The study that brought CAR-T to CLL: one in five heavily pretreated patients achieved complete remission, most of them lasting.
Primary analysis set (BTKi and venetoclax failure, n=49-50): CR/CRi 18-20%, ORR 42-47%, uMRD in blood 64%; complete responders had durable remissions beyond 2 years. Lancet 2023. Accelerated approval 14 March 2024. Efficacy is lower than in lymphoma, reflecting T-cell dysfunction in CLL.
- 18 out of 100 people had no sign of cancer on scans or tests with Liso-cel.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 47 out of 100 people had their tumour shrink with Liso-cel.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- 64 out of 100 people had no detectable disease on sensitive tests with Liso-cel.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- These results apply to the people the trial enrolled: Relapsed/refractory CLL/SLL after BTK inhibitor (and venetoclax in the primary analysis set): lisocabtagene maraleucel. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
137 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete response / CRi (primary analysis set)primary | Liso-cel | 49 | 18% | — | — | link |
| Overall response rate | Liso-cel | — | 47% | — | — | — |
| Undetectable MRD in blood | Liso-cel | — | 64% | — | — | — |
Pages like this
not linked directly; found by shared links- PersonStanley R. Riddell
Shares Lisocabtagene maraleucel, CD19, Chronic lymphocytic leukaemia, CAR-T cell therapy.
- PersonJae H. Park
Shares CD19, CAR-T cell therapy.
- TrialFELIX
Shares CD19, CAR-T cell therapy.
- IdeaNon-viral CAR-T (transposon or CRISPR knock-in) as the default manufacturing route
Shares CD19, CAR-T cell therapy.
- IdeaNon-profit, open-licence lentiviral vectors and producer cell lines for CAR-T
Shares CD19, CAR-T cell therapy.
- PersonDavid L. Porter
Shares CD19, Chronic lymphocytic leukaemia, CAR-T cell therapy.
- PersonRenier J. Brentjens
Shares CD19, CAR-T cell therapy.
- PersonNirali N. Shah
Shares CD19, CAR-T cell therapy.