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NCT04134117
Tisagenlecleucel In Primary CNS Lymphoma
Completed
Phase 1
Last updated 9 January 2026
What this trial tests
Phase 1 trial testing Tisagenlecleucel in Primary CNS Lymphoma in 13 participants. Completed in 14 April 2022.
Timeline
1 January 2019
Primary endpoint
14 April 2022
14 April 2022
14 April 2022
Quick facts
| Lead sponsor | Matthew J. Frigault, M.D. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 1 January 2019 |
| Primary completion | 14 April 2022 |
| Estimated completion | 14 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Tisagenlecleucel (TISAGENLECLEUCEL) — full drug profile →
Conditions studied
- Primary CNS Lymphoma — all drugs for Primary CNS Lymphoma →
- Refractory Primary CNS Lymphoma — all drugs for Refractory Primary CNS Lymphoma →
- Relapsed Primary CNS Lymphoma — all drugs for Relapsed Primary CNS Lymphoma →
Sponsor
Matthew J. Frigault, M.D.
Who can join
18 and older, any sex, with Primary CNS Lymphoma or Refractory Primary CNS Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, is researching the safety of tisagenlecleucel in participants with primary central nervous system lymphoma. . -The name of the study intervention is tisagenlecleucel.
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 -
State of the art in CAR T cell therapy for CD19+ B cell malignancies.
Frigault MJ, Maus MV. · · 2020 · cited 77× · PMID 32235098 · DOI 10.1172/jci129208 -
CAR T-Cell Therapy for B-Cell non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia: Clinical Trials and Real-World Experiences.
Vitale C, Strati P. · · 2020 · cited 63× · PMID 32670869 · DOI 10.3389/fonc.2020.00849 -
CAR T-cell-associated neurotoxicity in central nervous system hematologic disease: Is it still a concern?
Velasco R, Mussetti A, Villagrán-García M, Sureda A. · · 2023 · cited 39× · PMID 37090983 · DOI 10.3389/fneur.2023.1144414 -
Clinical Perspective: Treatment of Aggressive B Cell Lymphomas with FDA-Approved CAR-T Cell Therapies.
Leick MB, Maus MV, Frigault MJ. · · 2021 · cited 25× · PMID 33130313 · DOI 10.1016/j.ymthe.2020.10.022 -
CD19-Targeted Immunotherapies for Diffuse Large B-Cell Lymphoma.
Gambella M, Carlomagno S, Raiola AM, Giannoni L, et al · · 2022 · cited 21× · PMID 35280988 · DOI 10.3389/fimmu.2022.837457 -
Real-World Experiences of CAR T-Cell Therapy for Large B-Cell Lymphoma: How Similar Are They to the Prospective Studies?
Tang K, Nastoupil LJ. · · 2021 · cited 20× · PMID 35663108 · DOI 10.36401/jipo-21-2 -
CAR T-Cells for CNS Lymphoma: Driving into New Terrain?
Karschnia P, Blobner J, Teske N, Schöberl F, et al · · 2021 · cited 19× · PMID 34065471 · DOI 10.3390/cancers13102503
Verify or expand the search:
- PubMed search for NCT04134117
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tisagenlecleucel
Trials testing the same drug.
- NCT06785818 — Long-term Follow up Local Registry Study of Kymriah in South Korea · recruiting
- NCT05888493 — A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphom · Phase 3 · active not recruiting
- NCT05633615 — Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma · Phase 2 · recruiting
- NCT04456023 — Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphom · Phase 2 · withdrawn
- NCT04890236 — Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell L · EARLY_PHASE1 · completed
Other recruiting trials for Primary CNS Lymphoma
Currently open trials in the same condition.
- NCT05518383 — B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 · Phase 4 · recruiting
- NCT04947319 — Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study) · Phase 2 · active not recruiting
- NCT04627753 — Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL. · Phase 2 · recruiting
- NCT05036564 — Diagnosis; Objective RespOnse; THErApy · NA · recruiting
- NCT04006561 — Prospective Neurobehavioral Functions in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionat · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04134117 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Matthew J. Frigault, M.D.
- Last refreshed: 9 January 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/NCT04134117.
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