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The study that registered the third CAR-T cell product for lymphoma, built from a fixed one-to-one mix of two kinds of T cell, with fewer severe immune side effects than its predecessors.
Lisocabtagene maraleucel differs from the other two approved CD19 products in that the CD8 and CD4 chimeric antigen receptor T cells are manufactured separately and infused at equal target doses rather than as whatever ratio the patient's apheresis happened to contain. TRANSCEND NHL 001 was a seamless design study at 14 United States centres that tested three dose levels in sequence.
Of 344 patients who had leukapheresis, 269 received at least one dose. They had a median of three previous lines, 42 per cent were 65 or older, 67 per cent had chemotherapy-refractory disease and seven had secondary central nervous system involvement, a group usually excluded. In the 256 patients of the efficacy-evaluable set, 186 (73 per cent, 95 per cent confidence interval 66.8 to 78.0) had an objective response and 136 (53 per cent, 46.8 to 59.4) a complete response. Safety and activity did not differ by dose level, and the recommended target dose was 100 million chimeric antigen receptor positive T cells.
The toxicity figures are why the product is used in older and frailer patients: cytokine release syndrome in 42 per cent but grade 3 or worse in only 2 per cent, neurological events in 30 per cent with 10 per cent grade 3 or worse. One patient died of diffuse alveolar damage after a dose-limiting toxicity.
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.
269 treated.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rateprimary | Lisocabtagene maraleucel | 256 | 73% | - | - | link |
| Complete response rate | Lisocabtagene maraleucel | 256 | 53% | - | - | - |
| Grade 3 or worse cytokine release syndrome | Lisocabtagene maraleucel | 269 | 2% | - | - | - |
Shares BELINDA, TRANSFORM, Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote, JULIET and the tag lymphoma-evidence.
Shares Complete response, The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting, ICANS (neurotoxicity), Cytokine release syndrome (CRS) and the tag lymphoma-evidence.
Shares Complete response, ICANS (neurotoxicity), Cytokine release syndrome (CRS), Manufacturing cost and time for living and radioactive medicines and the tag lymphoma-evidence.
Shares Complete response, Objective response rate (ORR), Cytokine release syndrome (CRS), Manufacturing cost and time for living and radioactive medicines and the tag lymphoma-evidence.
Shares ICANS (neurotoxicity), Cytokine release syndrome (CRS), Manufacturing cost and time for living and radioactive medicines, CD19 and the tag lymphoma-evidence.
Shares Complete response, Objective response rate (ORR), Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting, Follicular lymphoma and the tag lymphoma-evidence.
Shares Complete response, Objective response rate (ORR), Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting, Follicular lymphoma and the tag lymphoma-evidence.
Shares Complete response, Objective response rate (ORR), Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting, Non-Hodgkin lymphoma (all types) and the tag lymphoma-evidence.