Clinical trial · Interventional
Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia
Safety and Clinical Activity of CD19 Chimeric Antigen Receptor T Cells in Treating Patients With Recurrent or Refractory CD19 Positive B Cell Acute Lymphoblastic Leukemia
NCT03599375CI-TRIAL-00037293unknownPhase 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 study aims to evaluate the safety and clinical activity of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in treating patients with recurrent or refractory CD19 positive B cell ccute lymphoblastic leukemia,and dynamically observe the changes of CAR-T in patients and the residual tumor.
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 |
|---|---|---|---|
| Leukemia, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-targeted CART cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- B-ALL treated with CD19 CART cell
- description
- The qualified CD19-targeted CART cells will be transferred to patient for 3 days as follow:D1,10% fraction;D2,30%;D3 60%. The number of CART cells for each course will be about 1×106/kg. If complete response (CR) or complete response with incomplete hemogram recovery (CRi) in hemogram is achieved after the first course of treatment, further treatment will be decided according to the clinical assessment and the wishes of the patient.If partial response (PR) is achieved after the first course, 1 or 2 courses of treatment will be continued. If there is no response (NR) after the first course, the treatment will be ceased or restarted based on the clinical assessment or patients' wishes. Treatent may be discontinued due to any severe toxicity, such as cytokine release syndrom.
- interventionNames
- Biological: CD19-targeted CART cells
Primary outcomes (1)
- measure
- overall response rate(ORR)
- timeFrame
- Participants will be followed for the duration of the treatment, with an expected average of 3 months.
- description
- ORR is defined as the proportion of partial responses plus complete responses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Recurrent or refractory B cell derived acute lymphoblastic leukemia (ALL) * Patients who have failed at least one line of a standard treatment without effective treatment measures at present * CD19 expression on the surface of B-ALL cells must be detected * KPS\>80 * Life expectancy \>3 months * Patients must have adequate cardiac function (no electrocardiogram with obvious abnormality, LVEF≥50%),adequate pulmonary function as indicated by room air oxygen saturation of \> 90%, and adequate renal function (Cr≤2.5 times of the normal range) * The alanine aminotransferase (ALT) and the aspartate aminotransferase (AST)≤ 3 times of the normal range, and the total bilirubin (TBIL)≤2.0mg/dl(34.2umol/L) * Hemoglobin(Hgb)≥80g/L * Without contraindication of apheresis and cell isolation * Patients and their families volunteer to participate in the research with signed written informed consent Exclusion Criteria: .Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease; another severe and/or life-threatening medical disease. * Evidence of uncontrolled current serious active infection * HIV/HBV/HCV infection * Pregnancy and nursing females * Systemic glucocorticoid therapy within one week
References
Publications (0)
Data not yet available
No reference posted for this study.