Clinical trial · Interventional
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
A Study of CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-cell Acute Lymphoblastic Leukemia
NCT03263208CI-TRIAL-00029998unknownPhase 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)
The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ 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 |
|---|---|---|---|
| B-cell Acute Lymphocytic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CAR-T | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19 CAR-T
- description
- A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Biological: CD19 CAR-T
Primary outcomes (2)
- measure
- safety as assessed by the occurence of study related adverse events
- timeFrame
- 30 days
- description
- number of participants with adverse events
- measure
- anti-tumor responses of CD19 CAR-T cells
- timeFrame
- 1 year
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. 2 years to 70 years, expected survival \> 3 months; * 2\. CD19 positive B-cell acute lymphoblastic leukemia; * 3\. ECOG \< 2; * 4\. The tumor load in the bone marrow is less than 60%; * 5\. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN,AST ≤2.5ULN,ALT ≤2.5ULN; kidney: Cr≤1.25ULN; Peripheral Blood: WBC ≥ 2.0×109/L, Hb ≥80 g/L, PLT ≥ 30×109/L); * 6\. No leukemia cells in the central nervous system; * 7\. No serious allergic constitution; * 8\. No other serous diseases that conflicts with the clinical program; * 9\. No other cancer history; * 10\. No serious mental disorder; * 11\. female participants of reproductive potential must have a negative serum pregnancy test; * 12\. Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: * 1\. Pregnant or lactating women; * 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\. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
References
Publications (0)
Data not yet available
No reference posted for this study.