Clinical trial · Interventional
The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma
NCT03101709CI-TRIAL-00026808unknownPhase 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 clinical study to observe the safety and feasibility of chimeric antigen receptor 19 (CART-19) cells in relapsed and refractory patients with CD19+ B cell lymphoma.
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 Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART-19 | Biological | Tisagenlecleucel | ALIAS |
| 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
Primary outcomes (1)
- measure
- safety as assessed by the occurence of study related adverse events
- timeFrame
- 6 months
- description
- monitor the occurence of study related adverse events
Secondary outcomes (2)
- measure
- efficacy assessed by anti-tumor activity of CART-19 cells
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years to 70 years, expected survival \> 3 months; 2. CD19 positive B-cell lymphoma; 3. KPS \>80; 4. Having at least one measurable lesions; 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN,AST ≤2.5ULN,ALT ≤2.5ULN; kidney: Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×109/L, Hb ≥90 g/L, 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 \>2.5ULN, Bilirubin \>3ULN,Creatinine\>1.25ULN 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.