Clinical trial · Interventional
CD19+Targeted CAR-T Cell Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma
NCT04271410CI-TRIAL-00065737unknownPhase 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)
This is a single arm study to evaluate the efficacy and safety of CD19-targeted CAR-T cells therapy for patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma.
Conditions
Conditions (5)
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 | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Leukemia, B-cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19 CAR-T cells treat
- description
- Patients will be be treated with CD19 CAR-T cells
- interventionNames
- Biological: CD19 CAR-T cells
Primary outcomes (2)
- measure
- Adverse events that related to treatment
- timeFrame
- 2 years
- description
- Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
- measure
- The response rate of CD19 CAR-T treatment in patients with relapse/refractory B Cell Leukemia and Lymphoma that treatment by CD19 CAR-T cells therapy
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed written informed consent; 2. Diagnose as relapsed/refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions: 1. Failed to standard chemotherapy regimens; 2. Relapse after complete remission, high-risk and / or refractory patients ; 3. Relapse after hematopoietic stem cell transplantation; 3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients); 4. Evidence for cell membrane CD19 expression; 5. All genders ,ages: 2 to 75 years; 6. The expect time of survive is above 3 months; 7. KPS\>60; 8. No serious mental disorders ; 9. Left ventricular ejection fraction ≥50% 10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN; 11. Sufficient renal function defined by creatinine clearance≤2 x ULN; 12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 13. With single or venous blood collection standards, and no other cell collection contraindications; 14. Ability and willingness to adhere to the study visit schedule and all protocol requirements. Exclusion Criteria: 1. Previous history of other malignancy; 2. Presence of uncontrolled active infection; 3. Evidence of disorder that need the treatment by glucocorticoids; 4. Active or chronic GVHD; 5. The patients treatment by inhibitor of T cell; 6. Pregnant or breasting-feeding women; 7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
References
Publications (0)
Data not yet available
No reference posted for this study.