Clinical trial · Interventional
4SCAR-T Therapy Post CD19-targeted Immunotherapy
4SCAR-T Therapy After Anti-CD19 Immunotherapy Targeting B Cell 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 (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation 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 |
|---|---|---|---|
| CD19 Negative B-cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 4SCAR-CD22/CD123/CD38/CD10/CD20 infusion
- description
- Patients who have relapsed after anti-CD19 immunotherapy or have CD19 negative B cell malignancies
- interventionNames
- Biological: Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20
Primary outcomes (1)
- measure
- Safety of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells
- timeFrame
- 24 weeks
- description
- Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
Secondary outcomes (1)
- measure
- Anti-tumor activity of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells
- timeFrame
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. B cell malignancies relapsed after anti-CD19 immunotherapy. 3. Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20. 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. Bacterial, fungal, or viral infection 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. 7. Judged difficult to cooporate for continued evaluation.
References
Publications (0)
Data not yet available