Clinical trial · Interventional
The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).
The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.
NCT02924753CI-TRIAL-00030971unknownPhase 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 is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-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 |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART-19 cells | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CART-19
- description
- patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Biological: CART-19 cells
Primary outcomes (1)
- measure
- safety as assessed by the occurrence of study related adverse events.
- timeFrame
- 6 months
- description
- monitor the occurrence of study related adverse events.
Secondary outcomes (2)
- measure
- efficacy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 4 years to 70 years, expected survival \> 3 months 2. CD19 positive B-cell acute lymphoblastic leukemia 3. Karnofsky Performance Status (KPS) \>70 4. Relapsed after allogeneic or autologous stem cell transplantation (SCT); 5. Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN),aspartate aminotransferase (AST) ≤2.5 ULN,ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L) 6. No serious allergic constitution 7. No other serous diseases that conflicts with the clinical program 8. No other cancer history 9. No serious mental disorder 10. Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: 1. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test) 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive 3. Active hepatitis B or hepatitis C infection 4. Recent or current use of glucocorticoid or other immunosuppressor 5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases 6. Transaminase \>2.5 ULN, Bilirubin \>3 ULN,Creatinine\>1.25 ULN 7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products 8. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results
References
Publications (0)
Data not yet available
No reference posted for this study.