Clinical trial · Interventional
Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia
NCT04740203CI-TRIAL-00049884unknownPhase 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)
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia
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, Adult | Adult B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T cells targeting CD19 and CD22 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T therapy
- description
- Administration of CD19 and CD22 CAR T-cells
- interventionNames
- Drug: CAR-T cells targeting CD19 and CD22
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Baseline up to 28 days after CAR-T cells infusion
- description
- Adverse events assessed according to NCI-CTCAE v5.0 criteria
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to 2 years after CAR-T cells infusion
- description
- Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Age≥15 years old * Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification * The immunophenotype of leukemia cells were CD19 and CD22 positive * Ph- or Ph- like negative * Anticipated survival time more than 12 weeks; * Those who voluntarily participated in this trial and provided informed consent. Exclusion Criteria: * History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; * Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; * Pregnant (or lactating) women; * Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); * Active infection of hepatitis B virus or hepatitis C virus; * Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; * Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; * Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; * Other uncontrolled diseases that were not suitable for this trial; * Patients with HIV infection; * Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
References
Publications (0)
Data not yet available
No reference posted for this study.