Clinical trial · Interventional
Dual Target CAR-T Cells in B-cell Acute Lymphoblastic Leukemia
Clinical Trial of CD19/CD22 Dual Target CAR-T Cells in the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
NCT04723901CI-TRIAL-00049639CAR-TunknownPhase 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)
Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.
Conditions
Conditions (4)
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 ALL | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Dual-target CAR-T Cells | — | UNRESOLVED | — |
| Refractory B Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Relapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dual target CAR-T cell therapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- Dual target CAR-T cell therapy
- interventionNames
- Biological: Dual target CAR-T cell therapy
Primary outcomes (1)
- measure
- Complete remission rate
- timeFrame
- From date of initial treatment to the end of follow up, up to 2 years
- description
- 1. No blasts in peripheral blood, no extramedullary leukemia; 2. Three-line bone marrow hematopoietic recovery, primitive cells \<5%; 3. Peripheral blood absolute neutrophil count\>1.0×10\^9/L; 4. Peripheral blood platelet count\>100×10\^9/L; 5. No recurrence within 4 weeks
Secondary outcomes (1)
- measure
- Overall survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must meet the following criteria to participate in this study: 1. 14-75 years old, no gender limit; 2. According to the 2020 World Health Organization (WHO) diagnostic criteria, it is diagnosed as relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL); 3. ECOG behavior status score is 0-2 points; 4. Expected survival time ≥ 3 months; 5. No contraindications to peripheral apheresis; 6. Flow cytometry confirms that the original cells express CD22; 7. Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression; 8. No serious heart, lung, liver or kidney disease; 9. Ability to understand and willing to sign the informed consent form for this trial. Exclusion Criteria: * Patients with any of the following cannot be included in this study: 1. The original cells expressing CD19 and CD22 are negative; 2. There is active infection; 3. Abnormal liver function ( glutamic-pyruvic transaminase\>1.5×ULN, glutamic oxalacetic transaminase\>2.5×ULN), abnormal renal function (serum creatinine\>1.5×ULN); 4. People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction; 5. HIV/AIDS patients; 6. Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose\>300mg/d; clopidogrel, dose\>75mg/d) treatment; 7. Those who received radiotherapy within 4 weeks before the start of the study (blood sampling); 8. Known or suspected drug abuse or alcohol dependence; 9. People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures; 10. Those who have participated in other clinical trials within 30 days; 11. Pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (Such as intrauterine device or condom); 12. The investigator judged that it is not suitable to participate in this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.