Clinical trial · Interventional
CD19-CART Treatment for ALL
Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL
NCT03232619CI-TRIAL-00047275completedPhase 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 study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.
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 Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CART | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CD19-CART with a murine scFv
- description
- All enrolled patients in this arm will receive CD19-CART with a murine scFv.
- interventionNames
- Biological: CD19 CART
- type
- EXPERIMENTAL
- label
- humanized CD19-CART
- description
- All enrolled patients in this arm will receive humanized CD19-CART.
- interventionNames
- Biological: CD19 CART
Primary outcomes (1)
- measure
- Radiological assessment
- timeFrame
- Month1 to Month12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. previously identified as CD19+ ALL. 2. ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT. 3. Expected survival \>12W. 4. Creatinine \< 2.5 mg/dl. 5. Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) \< 3x normal 6. Bilirubin \<2.0 mg/dl 7. Voluntary informed consent is given. Exclusion Criteria: 1. Pregnant or lactating women. 2. Uncontrolled active infection. 3. Active hepatitis B or hepatitis C infection. 4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. 5. Previously treatment with any gene therapy products. 6. Any uncontrolled active medical disorder that would preclude participation as outlined. 7. HIV infection.
References
Publications (0)
Data not yet available
No reference posted for this study.