Clinical trial · Interventional
Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia
A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukaemia
NCT02808442CI-TRIAL-00054352PALLcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the safety and feasibility of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Relapsed B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UCART19 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- UCART19
- interventionNames
- Biological: UCART19
Primary outcomes (1)
- measure
- Incidence and Severity of Adverse Events
- timeFrame
- From inclusion to Month 12
- description
- Adverse events assessed according to NCI-CTCAE v5.0 criteria
Secondary outcomes (1)
- measure
- Molecular Remission Rate
- timeFrame
- At Day 28 after the first UCART19 infusion
- description
- Proportion of patients in whom a molecular Complete Remission (CR) or a Complete Remission with incomplete blood recovery (CRi) is observed (i.e. a CR or CRi combined to a Minimal residual disease \<10-4).
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with relapsed or refractory CD19-positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options. * Estimated life expectancy ≥ 12 weeks * Lansky (age \< 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50 Exclusion Criteria: * Burkitt leukemia * CD19-negative B-cell leukemia * Active Central Nervous System (CNS) leukemia * Active acute or chronic Graft-versus-Host Disease (GvHD) requiring systemic use therapy within 4 weeks before UCART19 infusion * Patients with autoimmune disease requiring systemic immunosuppression therapy that cannot be stopped * History of CRS grade 4 related to previous CAR T cell therapy * Contraindication to Alemtuzumab administration
References
Publications (2)
- RESULTBenjamin R, Graham C, Yallop D, Jozwik A, Mirci-Danicar OC, Lucchini G, Pinner D, Jain N, Kantarjian H, Boissel N, Maus MV, Frigault MJ, Baruchel A, Mohty M, Gianella-Borradori A, Binlich F, Balandraud S, Vitry F, Thomas E, Philippe A, Fouliard S, Dupouy S, Marchiq I, Almena-Carrasco M, Ferry N, Arnould S, Konto C, Veys P, Qasim W; UCART19 Group. Genome-edited, donor-derived allogeneic anti-CD19 chimeric antigen receptor T cells in paediatric and adult B-cell acute lymphoblastic leukaemia: results of two phase 1 studies. Lancet. 2020 Dec 12;396(10266):1885-1894. doi: 10.1016/S0140-6736(20)32334-5. PMID 33308471
- DERIVEDLi YR, Zhu Y, Fang Y, Lyu Z, Yang L. Emerging trends in clinical allogeneic CAR cell therapy. Med. 2025 Aug 8;6(8):100677. doi: 10.1016/j.medj.2025.100677. Epub 2025 May 13. PMID 40367950