Clinical trial · Interventional
CAR-T Immunotherapy Targeting CD19- ALL
CART Immunotherapy Targeting CD19 Negative Acute Lymphoblastic Leukemia
- 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 will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
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 Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
- description
- Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies
- interventionNames
- Biological: 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
Primary outcomes (1)
- measure
- Safety of infusion
- timeFrame
- 24 weeks
- description
- Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
Secondary outcomes (1)
- measure
- Anti-tumor activity of CART
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age older than 6 months. 2. Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy. 3. Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR. 4. The KPS score over 80 points, and survival time is more than 1 month. 5. Greater than Hgb 80 g/L. 6. No contraindications to blood cell collection. Exclusion Criteria: 1. Complications with other active diseases, and difficult to assess patient response. 2. Bacteria, fungus, or virus infection, and unable to control. 3. Living with HIV. 4. Active HBV and HCV infection. 5. Pregnant and nursing mothers. 6. Under systemic steroid use within a week of the treatment.
References
Publications (0)
Data not yet available