# ZUMA-1

Source: https://onco.cc/trials/zuma-1/  
OnCo record `zuma-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

ZUMA-1 was the trial that brought CAR-T cell therapy to large B-cell lymphoma: a single infusion produced remissions in most patients whose disease had resisted chemotherapy, and about four in ten stayed in remission for years.

## Summary

ZUMA-1 was the pivotal phase 1/2 study of axicabtagene ciloleucel (KTE-C19), a CD19-directed CAR-T, in patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma or transformed follicular lymphoma that was refractory to the last chemotherapy or had relapsed within a year of autologous transplant. Patients received lymphodepleting fludarabine and cyclophosphamide and a single infusion; the primary endpoint was objective response rate.

Most patients responded and more than half achieved a complete response, a striking result in a population whose expected response to salvage chemotherapy was poor, and a large minority remained in durable remission at five years. Cytokine release syndrome and neurological toxicity were frequent but mostly reversible. The product was approved in the United States in October 2017, the first CAR-T for lymphoma, and ZUMA-7 later moved it into second line.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT02348216
- Phase: 1/2
- Setting: Refractory large B-cell lymphoma (diffuse large B-cell, primary mediastinal and transformed follicular lymphoma): single-arm axicabtagene ciloleucel CAR-T
- Sponsor: Kite (Gilead)
- Enrolled: 307
- Result: High objective and complete response rates in refractory large B-cell lymphoma with durable remissions in a large minority; approved in October 2017.
- Outcomes: Objective response rate: Axicabtagene ciloleucel 82%; Complete response rate: Axicabtagene ciloleucel 54%; Ongoing response at median follow-up of 15.4 months: Axicabtagene ciloleucel 42%; Overall survival at 18 months: Axicabtagene ciloleucel 52%; Grade 3 or higher cytokine release syndrome: Axicabtagene ciloleucel 13%; Grade 3 or higher neurologic events: Axicabtagene ciloleucel 28%

## Sources

- ClinicalTrials.gov NCT02348216: https://clinicaltrials.gov/study/NCT02348216

## 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: [JULIET](https://onco.cc/trials/juliet/), [TRANSCEND NHL 001](https://onco.cc/trials/transcend-nhl-001/)
- cancers: [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [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/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- drugs: [Axicabtagene ciloleucel](https://onco.cc/drugs/axicabtagene-ciloleucel/), [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/)
- companies: [Gilead Sciences (incl. Kite)](https://onco.cc/companies/gilead/)
- people: [Sattva S. Neelapu](https://onco.cc/people/sattva-neelapu/)
- terms: [Cytokine release syndrome and ICANS: grading and management](https://onco.cc/terms/lymphoma-tx-crs-icans/)
- ideas: [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/)

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