Clinical trial · Interventional
CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Pilot Study of the Efficacy and Safety of CD19 Targeted Chimeric Antigen Receptor Engineered T Cell in the Treatment of Relapsed or Refractory CD19 Positive Acute Myeloid Leukemia (AML)
NCT03896854CI-TRIAL-00071811unknownPhase 1 / Phase 2ClinicalTrials.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 is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19 positive relapsed or refractory acute myeloid leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART-19 | Biological | Tisagenlecleucel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19 positive relapsed or refractory acute myeloid leukemia
- description
- MICM typing confirmed CD19 positive relapsed and refractory acute myeloid leukemia
- interventionNames
- Biological: CART-19
Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- 12 months
- description
- Adverse events are evaluated with CTCAE V4.03
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients with CD19+ relapsed/refractory acute myeloid leukemia * Age 6-65 years. * Left ventricular ejection fractions≥ 0.5 by echocardiography. * Creatinine \< 1.6 mg/dL. * Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal. * Bilirubin \<2.0 mg/dL. * Karnofsky performance status ≥ 60 * Expected survival time ≥ 3 months (according to investigator's judgement) Exclusion Criteria: * Pregnant or lactating women. * Uncontrolled active infection. * Active hepatitis B or hepatitis C infection. * Class III/IV cardiovascular disability according to the New York Heart Association Classification. * HIV infection. * Patients with history of seizure * Active central nervous system leukemia
References
Publications (0)
Data not yet available
No reference posted for this study.