Clinical trial · Interventional
CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
Phase I/II Study of CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
NCT03146533CI-TRIAL-00027649unknownPhase 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 clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor 19 (CD19 CART) 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 |
|---|---|---|---|
| CD19 CART | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19 CART
- description
- patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CD19 CART cells. The CD19 CART cells are to be administered on day0,day1,day2.
- interventionNames
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Biological: CD19 CART
Primary outcomes (6)
- measure
- safety as assessed by the occurence of study related adverse events
- timeFrame
- 6 months
- description
- monitor the occurence of study related adverse events
- measure
- observe the maximum tolerated dose (MTD)
- timeFrame
- 2 months
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.