Clinical trial · Interventional
CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.
Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
NCT03614858CI-TRIAL-00071805unknownPhase 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/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic 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 |
|---|---|---|---|
| Leukemia, B-cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART-19/22 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Experimental: Cohort 1 Intervention: Biological: CART-19/22 This cohort will determine the safety and efficacy of targeted CD19/CD22 chimeric Antigen Receptor Engineered T Cell Immunotherapy (CART) in the Treatment of CD19/CD22 Positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
- interventionNames
- Biological: CART-19/22
Primary outcomes (1)
- measure
- Number of 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+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to \<2 year). The study will enroll 20 evaluable patients as follows: * 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.