Clinical trial · Interventional
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT04012879CI-TRIAL-00039411unknownPhase 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 study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory acute lymphoblasic leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Relapsed Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CART | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- study group
- description
- After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10\^4 cells/kg in 36-96 hours
- interventionNames
- Combination Product: CD19 CART
Primary outcomes (1)
- measure
- recovery rate of patients being treated with CD19CAR-T
- timeFrame
- 6 months
- description
- the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis with Relapsed or refractory acute lymphocyte leukemia with CD19 positive 2. Age 18 to 65 years old, both male and female; 3. Is expected to survive more than 12 weeks; 4. Physical condition is good: 0-1 score ECOG score; 5. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body; 6. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form. Exclusion Criteria: 1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness; 2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more; 3. Pregnancy and lactation women; 4. Patients who have participated in other clinical trials or other clinical trials in the past 30 days; 5. The Investigator believe the patients should not participate in this experiment.
References
Publications (0)
Data not yet available
No reference posted for this study.