# TRANSCEND NHL 001

Source: https://onco.cc/trials/transcend-nhl-001/  
OnCo record `transcend-nhl-001` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-10-01
- Also known as: JCAR017; liso-cel pivotal study; TRANSCEND NHL 001
- Tags: lymphoma-evidence
- Registry id: NCT02631044
- Phase: 1
- Setting: Relapsed or refractory large B-cell lymphoma after at least one prior line, including double-hit and transformed disease: lisocabtagene maraleucel at three dose levels
- Sponsor: Juno Therapeutics, a Subsidiary of Celgene
- Enrolled: 269
- Result: Objective response in 73 per cent and complete response in 53 per cent of 256 evaluable patients, with grade 3 or worse cytokine release syndrome in 2 per cent.
- Outcomes: Objective response rate: Lisocabtagene maraleucel 73%; Complete response rate: Lisocabtagene maraleucel 53%; Grade 3 or worse cytokine release syndrome: Lisocabtagene maraleucel 2%
- Replication: Confirmed in the randomised second-line setting by TRANSFORM.

## Sources

- ClinicalTrials.gov NCT02631044: https://clinicaltrials.gov/study/NCT02631044
- Lancet 2020: https://doi.org/10.1016/S0140-6736(20)31366-0

## Connected records

- cancers: [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [Follicular lymphoma](https://onco.cc/cancers/follicular-lymphoma/), [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/), [Primary mediastinal (thymic) large B-cell lymphoma](https://onco.cc/cancers/primary-mediastinal-b-cell-lymphoma/)
- fronts: [Cell Therapy](https://onco.cc/fronts/cell-therapy/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- targets: [CD19](https://onco.cc/targets/cd19/)
- drugs: [Lisocabtagene maraleucel](https://onco.cc/drugs/lisocabtagene-maraleucel/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- terms: [Complete response](https://onco.cc/terms/complete-response/), [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [Double-hit / high-grade B-cell lymphoma](https://onco.cc/terms/double-hit-lymphoma/), [ICANS (neurotoxicity)](https://onco.cc/terms/icans/), [Objective response rate (ORR)](https://onco.cc/terms/orr/), [The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting](https://onco.cc/terms/lymphoma-tx-car-t-pathway/)
- trials: [BELINDA](https://onco.cc/trials/belinda/), [JULIET](https://onco.cc/trials/juliet/), [TRANSFORM](https://onco.cc/trials/transform/), [ZUMA-1](https://onco.cc/trials/zuma-1/), [ZUMA-7](https://onco.cc/trials/zuma-7/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/), [Older and multimorbid patients are excluded and undertreated](https://onco.cc/bottlenecks/b-aging-comorbidity/)
- key papers: [Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study](https://onco.cc/key-papers/paper-transcend-nhl-001-liso-cel-lancet-2020/)
- roadmaps: [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](https://onco.cc/roadmaps/lymphoma-roadmap/)
- ideas: [Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote](https://onco.cc/ideas/lymphoma-ev-manufacturing-time-as-a-trial-endpoint/)

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JSON: https://onco.cc/api/v1/entities/transcend-nhl-001.json