# ZUMA-7

Source: https://onco.cc/trials/zuma-7/  
OnCo record `zuma-7` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The trial that moved CAR-T ahead of transplant as second-line treatment for early-relapsing large B-cell lymphoma, with a survival benefit.

## Summary

ZUMA-7, trial NCT03391466 sponsored by Kite and Gilead and published in the New England Journal of Medicine in 2022 with survival results in 2023, moved CAR-T ahead of transplant as second-line treatment for large B-cell lymphoma that is refractory or relapses within twelve months of first-line therapy. It randomised 359 patients to axicabtagene ciloleucel or salvage chemotherapy followed by autologous transplant, met its primary event-free survival endpoint with a large effect and later showed an overall survival benefit, while only about a third of the standard arm ever reached transplant, leading to approval in the second line in April 2022. OnCo links it to lymphoma, CAR-T, autologous transplant, axi-cel, Sattva S. Neelapu, Jason R. Westin, Frederick L. Locke and the manufacturing bottleneck. Whether CAR-T should move into the first line for high-risk patients is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03391466
- Phase: 3
- Setting: Large B-cell lymphoma refractory or relapsed within 12 months of frontline therapy: axi-cel vs salvage chemotherapy + autologous transplant
- Sponsor: Kite / Gilead
- Enrolled: 359
- Result: EFS HR 0.40; OS HR 0.73; 4-year OS 54.6% vs 46.0%.
- Outcomes: Event-free survival (median): Axi-cel 8.3 months vs Standard care 2 months, HR 0.4; Overall survival at 4 years: Axi-cel 54.6% vs Standard care 46%, HR 0.73
- Replication: TRANSFORM (liso-cel) confirmed the second-line CAR-T EFS benefit; BELINDA (tisagenlecleucel) was negative, attributed to design and bridging differences.

## Sources

- ClinicalTrials.gov NCT03391466: https://clinicaltrials.gov/study/NCT03391466
- OS analysis NEJM 2023: https://www.nejm.org/doi/full/10.1056/NEJMoa2301665

## Connected records

- 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/)
- trials: [BELINDA](https://onco.cc/trials/belinda/), [JULIET](https://onco.cc/trials/juliet/), [TRANSCEND NHL 001](https://onco.cc/trials/transcend-nhl-001/)
- ideas: [Hospital-based CAR-T manufacturing at cost through a public network](https://onco.cc/ideas/idea-fund-public-car-t-manufacturing/), [Hospital-made CAR-T under one shared regulatory master file](https://onco.cc/ideas/idea-reg-point-of-care-cart-network/), [In vivo CAR-T as a vial on the shelf: a cost and access trial in lymphoma](https://onco.cc/ideas/idea-reg-in-vivo-cart-off-the-shelf-vial/), [Non-viral CAR-T (transposon or CRISPR knock-in) as the default manufacturing route](https://onco.cc/ideas/idea-reg-non-viral-cart-manufacturing/), [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/)
- cancers: [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [Primary mediastinal (thymic) large B-cell lymphoma](https://onco.cc/cancers/primary-mediastinal-b-cell-lymphoma/)
- technologies: [Autologous stem cell transplant (high-dose therapy)](https://onco.cc/technologies/autologous-stem-cell-transplant/), [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- drugs: [Axicabtagene ciloleucel](https://onco.cc/drugs/axicabtagene-ciloleucel/)
- companies: [Gilead Sciences (incl. Kite)](https://onco.cc/companies/gilead/)
- terms: [Autologous stem cell transplant (ASCT)](https://onco.cc/terms/autologous-transplant/), [Bridging therapy](https://onco.cc/terms/bridging-therapy/), [Event-free / disease-free survival (EFS, DFS, iDFS, RFS)](https://onco.cc/terms/efs/), [Lymphoma treatments that did not work: the negative trials worth knowing](https://onco.cc/terms/lymphoma-tx-failed-and-negative/), [Overall survival (OS)](https://onco.cc/terms/os/), [Salvage therapy](https://onco.cc/terms/salvage-therapy/), [Stem cell transplant in lymphoma: what it is still for](https://onco.cc/terms/lymphoma-tx-transplant-role/), [The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting](https://onco.cc/terms/lymphoma-tx-car-t-pathway/), [Transplant or CAR-T at second line in diffuse large B-cell lymphoma](https://onco.cc/terms/lymphoma-decision-transplant-or-car-t/)
- people: [Frederick L. Locke](https://onco.cc/people/frederick-locke/), [Jason R. Westin](https://onco.cc/people/jason-westin/), [Sattva S. Neelapu](https://onco.cc/people/sattva-neelapu/)
- pairings: [Early relapse: CAR-T before transplant](https://onco.cc/pairings/car-t-before-transplant-lbcl/)
- key papers: [Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma](https://onco.cc/key-papers/paper-belinda-tisagenlecleucel-second-line-nejm-2022/), [TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma](https://onco.cc/key-papers/paper-transform-liso-cel-lancet-2022/), [ZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma](https://onco.cc/key-papers/paper-zuma-1-axi-cel-nejm-2017/), [ZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early](https://onco.cc/key-papers/paper-zuma-7-axi-cel-second-line-nejm-2022/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/)

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