Actively Recruiting
CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-06-05
37
Participants Needed
1
Research Sites
1017 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Soochow University
Lead Sponsor
N
National Natural Science Foundation of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 T and combination with other regimens may reduce the relapse rate. The investigators first conducted CD22/CD19 CAR T-cells and auto-HSCT "sandwich " strategy as consolidation therapy in patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.
CONDITIONS
Official Title
CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) with either no suitable allogeneic HSCT donor or refusal of allogeneic HSCT
- Positive expression of CD19 and CD22 in blood or bone marrow cells by flow cytometry
- Cardiac ultrasound showing left ventricular ejection fraction of 50% or higher
- Creatinine level 1.6 mg/dl or less
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) levels no more than 3 times the normal range
- Total bilirubin 2.0 mg/dl or less
- Pulmonary function with grade 1 or less dyspnea and oxygen saturation above 91% without oxygen
- Age between 15 and 65 years inclusive
- Passed T-cell amplification test
- Expected survival of more than 3 months
You will not qualify if you...
- Recurrence of only isolated extramedullary lesions
- Presence of other malignant tumors
- Previous treatment with anti-CD19, anti-CD22, or anti-CD3 therapies
- Use of immunosuppressants within 2 weeks before consent or planned use after consent
- Uncontrolled active infections
- HIV infection
- Active hepatitis B or C infection
- History of severe reaction to aminoglycoside antibiotics
- History or presence of serious central nervous system conditions such as epilepsy, seizures, paresis, aphasia, stroke, brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Sheng-Li Xue, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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