Clinical trial · Interventional
Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
NCT05333302CI-TRIAL-00080247unknownPhase 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)
The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
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 |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Lymphoblastic B-Cell Lymphoma | Burkitt Lymphoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CAR-T-cells | Biological | — | UNRESOLVED |
| Tocilizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19 CAR-T cells immunotherapy
- description
- After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells
- interventionNames
- Biological: CD19 CAR-T-cells
- Drug: Tocilizumab
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- 1 month
- description
- Adverse events will be graded according to the CTCAE v5.0
Secondary outcomes (4)
- measure
- Objective Response Rate (ORR) (CR+CRi+CRm)
- timeFrame
- 28 days after CAR-T cells infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma; * Karnofsky or Lansky performance scale greater or equal to 70; * T-cells count in peripheral blood \>150 cells/µL; * Written informed consent. Exclusion Criteria: * primary immunodeficiencies or genetic syndromes; * neurologic diseases; * autoimmune diseases or polyallergie; * transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion; * GvHD grade 2-4; * uncontrolled systemic infection; * hypoxia (Sp02\<90%) * severe hepatic dysfunction: ALT or AST \>=3x upper limit of normal for age; * renal dysfunction: serum creatinine level \>=3x upper limit of normal for age; * positive serology for human immunodeficiency virus (HIV), active hepatite C or B; * pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.