Clinical trial · Interventional
CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).
Clinical Trial for the Safety and Efficacy of Induction Chemotherapy With Azacitidine+Venetoclax (VA) and Bridging CD19CD22 CAR-T Therapy in Adult Patients With Newly Diagnosed High-Risk and Ph-negative (Ph-) B-ALL
NCT06078306CI-TRIAL-00076338unknownPhase 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 induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL
Conditions
Conditions (3)
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 Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| High Risk Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
| Ph-Negative ALL | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine Injection | Drug | Azacitidine | ALIAS |
| CD19CD22 CAR-T | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T therapy
- description
- Therapeutic outcomes in adults with Ph- B-ALL have substantially improved in the last decade, with complete remission (CR) and long-term overall survival (OS) rates of around 90% and 40%-50%, respectively. The presence of measurable residual disease (MRD) is the strongest predictor of relapse in B-ALL. In this study, high risk Ph- B-ALL patients receive the induction chemotherapy with Azacitidine+Venetoclax. After induction chemotherapy with Azacitidine+Venetoclax (VA regime), each subject receives CD19CD22 CAR-T cells by intravenous infusion. The patients with MRD negative will undergo HSCT.
- interventionNames
- Drug: Azacitidine Injection
- Drug: Venetoclax
- Drug: CD19CD22 CAR-T
Primary outcomes (1)
- measure
- Complete Remission Rate
- timeFrame
- The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
- description
- MRD Negative Remission Rate after CD19CD22 cell therapy
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age≥18 and ≤65 years old 2. Newly diagnosed and high risk B-ALL according to the 2022 WHO classification 3. The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-; 4. Anticipated survival time more than 12 weeks; 5. Those who voluntarily participated in this trial and provided informed consent. Exclusion Criteria: 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 5. Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus 6. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; 7. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 8. Other uncontrolled diseases that were not suitable for this trial; 9. 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.