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NCT05459571: ZUMA-24
Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma
Phase 2 trial testing Axicabtagene Ciloleucel in Relapsed or Refractory Large B-cell Lymphoma in 35 participants. Completed in 24 November 2025.
24 November 2025
Quick facts
| Lead sponsor | Kite, A Gilead Company |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 9 August 2022 |
| Primary completion | 24 November 2025 |
| Estimated completion | 24 November 2025 |
| Sites | 16 locations across United States |
Drugs / interventions tested
- Axicabtagene Ciloleucel — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
Conditions studied
- Relapsed or Refractory Large B-cell Lymphoma — all drugs for Relapsed or Refractory Large B-cell Lymphoma →
Sponsor
Kite, A Gilead Company — full company profile →
Who can join
18 and older, any sex, with Relapsed or Refractory Large B-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical study is to learn more about the study drug, axicabtagene ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the outpatient setting.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
CAR-T cell therapy for cancer: current challenges and future directions.
Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, et al · · 2025 · cited 81× · PMID 40610404 · DOI 10.1038/s41392-025-02269-w -
The pathogenesis, diagnosis, prevention, and treatment of CAR-T cell therapy-related adverse reactions.
Li Y, Ming Y, Fu R, Li C, et al · · 2022 · cited 37× · PMID 36313336 · DOI 10.3389/fphar.2022.950923 -
CAR T-cell toxicities: from bedside to bench, how novel toxicities inform laboratory investigations.
Perna F, Parekh S, Diorio C, Smith M, et al · · 2024 · cited 19× · PMID 38861351 · DOI 10.1182/bloodadvances.2024013044 -
Telemedicine in Hematopoietic Cell Transplantation and Chimeric Antigen Receptor-T Cell Therapy.
Gandhi AP, Lee CJ. · · 2023 · cited 13× · PMID 37627136 · DOI 10.3390/cancers15164108 -
Updates on Chimeric Antigen Receptor T-Cells in Large B-Cell Lymphoma.
Saleh K, Khalife N, Arbab A, Khoury R, et al · · 2024 · cited 2× · PMID 39767716 · DOI 10.3390/biomedicines12122810 -
Outpatient axicabtagene ciloleucel for relapsed/refractory large B-cell lymphoma: ZUMA-24 primary analysis.
Leslie LA, Baird JH, Flinn IW, Tees M, et al · · 2025 · PMID 40948517 · DOI 10.62347/gjnn1023 -
EHA2024 Hybrid Congress
· 2024 -
PB2346: ZUMA-24: A PHASE 2, OPEN-LABEL, MULTICENTER STUDY OF AXICABTAGENE CILOLEUCEL IN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA GIVEN WITH CORTICOSTEROIDS IN THE OUTPATIENT SETTING
Leslie L, Tees M, Flinn I, Rodriguez T, et al · · 2023
Verify or expand the search:
- PubMed search for NCT05459571
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Axicabtagene Ciloleucel
Trials testing the same drug.
- NCT07042438 — Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Expo · Phase 2 · recruiting
- NCT06935136 — Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large · NA · not yet recruiting
- NCT06912529 — Axicabtagene Ciloleucel CAR T-cells in Patients With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma · Phase 2 · terminated
- NCT05077527 — Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma · Phase 1 · recruiting
- NCT06826118 — Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma · Phase 2 · recruiting
Other Kite, A Gilead Company trials
Trials by the same sponsor.
- NCT05537766 — Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies · Phase 2 · terminated
- NCT04789408 — Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia · Phase 1 · terminated
- NCT04880434 — Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) · Phase 2 · completed
- NCT04314843 — Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma · Phase 1 · terminated
- NCT04002401 — Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cel · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05459571 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kite, A Gilead Company
- Last refreshed: 2 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05459571.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing