NCT04781634 a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL
| NCT ID | NCT04781634 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chongqing Precision Biotech Co., Ltd |
| Condition | B-ALL |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-03-07 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B -ALL
Eligibility Criteria
Inclusion Criteria: 1. Signed written informed consent 2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions: 1. Failed to standard chemotherapy regimens; 2. Relapse after complete remission, high-risk and / or refractory patients ; 3. Relapse after hematopoietic stem cell transplantation; 3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients) 4. Evidence for cell membrane CD19 or CD22 expression 5. All genders ages: 2 to 75 years 6. The expect time of survive is above 3 months; 7. KPS\>60 8. No serious mental disorders ; 9. Left ventricular ejection fraction ≥50% 10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x