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ZUMA-2 showed that CD19 CAR-T cells could produce deep and lasting remissions in mantle cell lymphoma that had stopped responding to BTK inhibitors, a group that previously had few options.
ZUMA-2 was a single-arm phase 2 study of brexucabtagene autoleucel (KTE-X19), a CD19-directed CAR-T manufactured with a process that removes circulating lymphoma cells, in patients with relapsed or refractory mantle cell lymphoma after up to five prior therapies including a BTK inhibitor. The primary endpoint was objective response rate by independent review.
Most treated patients responded and a majority achieved complete remission, with durable responses in a substantial share at long follow-up, including patients with TP53 mutations and blastoid morphology. Cytokine release syndrome and neurological events were common but largely reversible. The product was approved in the United States in July 2020, the first CAR-T for mantle cell lymphoma.
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.
105 enrolled.
95% CI 84 to 98; median follow-up 12.3 months
Source95% CI 53 to 78
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response (independent review, primary efficacy analysis)primary | KTE-X19 (brexucabtagene autoleucel) | 60 | 93% | - | - | link |
| Complete response (primary efficacy analysis) | KTE-X19 (brexucabtagene autoleucel) | 60 | 67% | - | - | link |
| Objective response (intention to treat) | KTE-X19 (brexucabtagene autoleucel) | 74 | 85% | - | - | link |
| Progression-free survival at 12 months | KTE-X19 (brexucabtagene autoleucel) | 60 | 61% | - | - | link |
| Overall survival at 12 months | KTE-X19 (brexucabtagene autoleucel) | 60 | 83% | - | - | link |
| Grade 3 or higher cytokine release syndrome | KTE-X19 (brexucabtagene autoleucel) | 68 | 15% | - | - | link |
| Grade 3 or higher neurologic events | KTE-X19 (brexucabtagene autoleucel) | 68 | 31% | - | - | link |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Cytokine release syndrome and ICANS: grading and management, Gilead Sciences (incl. Kite), CAR-T cell therapy, Non-Hodgkin lymphoma (all types) and the tag subtype-trials.
Shares Cytokine release syndrome and ICANS: grading and management, Gilead Sciences (incl. Kite), CAR-T cell therapy, Non-Hodgkin lymphoma (all types) and the tag subtype-trials.
Shares Non-Hodgkin lymphoma (all types) and the tag subtype-trials.
Shares Non-Hodgkin lymphoma (all types) and the tag subtype-trials.
Shares Non-Hodgkin lymphoma (all types) and the tag subtype-trials.
Shares Brexucabtagene autoleucel, Gilead Sciences (incl. Kite), Mantle cell lymphoma.
Shares Michael L. Wang, Brexucabtagene autoleucel, Gilead Sciences (incl. Kite), Mantle cell lymphoma.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/