Status:
NOT_YET_RECRUITING
CD22/CD19 CAR-T and Blinatumomab Combined With Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Acute Lymphobkastic Leukemia
Eligibility:
All Genders
15-65 years
Phase:
PHASE2
Brief Summary
Chimeric antigen receptor T-cell (CAR-T) therapy has achieved remarkable efficacy in B-cell acute lymphoblastic leukemia (B-ALL). However, relapse after CAR-T has been a major issue. Multi-antigen CAR...
Eligibility Criteria
Inclusion
- subjects with a primary diagnosis of B-ALL who have any of the following: (a) no suitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT;
- positive expression of CD19 and CD22 in peripheral blood or bone marrow primary cells detected by flow cytometry;
- cardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl; alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) with oxygen saturation \> 91% without oxygenation;
- subjects aged 15-65 years (including 15 and 65 years), regardless of gender;
- T-cell amplification test pass;
- expected survival \> 3 months.
Exclusion
- patients with recurrence of only isolated extramedullary lesions;
- combination of other malignant tumors;
- previously treated with anti-CD19 or/and CD22 or/and CD3 therapies;
- immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent;
- uncontrolled active infections;
- HIV infection;
- active hepatitis B or hepatitis C infection;
- history of severe tachyphylaxis to aminoglycoside antibiotics;
- history or presence of clinically relevant Central Nervous System (CNS) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06985498
Start Date
June 1 2026
End Date
September 1 2029
Last Update
August 7 2025
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