Clinical trial · Interventional
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
NCT03671460CI-TRIAL-00034878unknownPhase 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 is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
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 Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
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
- description
- Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
- interventionNames
- Biological: CD19 CAR-T cells
Primary outcomes (1)
- measure
- Percentage of adverse events
- timeFrame
- 6 months
- description
- Percentage of participants with adverse events
Secondary outcomes (2)
- measure
- complete remission rate
- timeFrame
- 6 months
- description
- The percentage of participants who achieved complete remission (CR) over all participants (CRR).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
Inclusion Criteria: 1. More than 1 year; 2. CD19 positive B-cell acute lymphoblastic leukemia; 3. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L. 4. Expected to survive for more than 3 months; 5. Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: 1. Recent or current use of glucocorticoid or other immunosuppressor; 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive; 3. Has a graft-versus-host response and requires the use of immunosuppressants； 4. Drug uncontrollable central nervous system leukemia； 5. Pregnant or lactating female； 6. The patient did not agree to use effective contraception during the treatment period and for the following 1 year； 7. A history of other malignant tumors; 8. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.