Clinical trial · Interventional
A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies
NCT03050190CI-TRIAL-00123402terminatedN/AClinicalTrials.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 study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies. 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 Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Therapeutic 4SCAR19 cells | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapeutic 4SCAR19 cells
- description
- Patients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells.
- interventionNames
- Genetic: Therapeutic 4SCAR19 cells
Primary outcomes (1)
- measure
- Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events
- timeFrame
- 24 weeks
- description
- physiological parameter (for safety, measuring cytokine response, fever, symptoms)
Secondary outcomes (1)
- measure
- Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B cell malignancies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
Show eligibility criteria text
Inclusion Criteria: 1. aged more than 6 months. 2. malignant B cell surface expression CD19 molecules. 3. the KPS score over 80 points, and survival time is more than 3 months. 4. greater Hgb 80 g/L. 5. no contraindications to solid and cell separation Exclusion Criteria: 1. accompanied with other active diseases, the treatment is difficult to correct. 2. bacteria, fungus, or virus infection, unable to control. 3. people living with HIV. 4. active HBV and HCV infection. 5. of pregnancy and nursing mothers. 6. before entering the test of the use of glucocorticoid systemic treatment within a week. 7. confirmed before used CAR - but invalid
References
Publications (1)
- DERIVEDNair S, Wang JB, Tsao ST, Liu Y, Zhu W, Slayton WB, Moreb JS, Dong L, Chang LJ. Functional Improvement of Chimeric Antigen Receptor Through Intrinsic Interleukin-15Ralpha Signaling. Curr Gene Ther. 2019;19(1):40-53. doi: 10.2174/1566523218666181116093857. PMID 30444200