# 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.

## Sources

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

## Connected records

- 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/)
- 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/)

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