CD22/CD19 CAR-T and Blinatumomab Combined With Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL

Phase 2

Not yet recruiting

• Conditions: Acute Lymphobkastic Leukemia

• Registration Number: NCT06985498
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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 T and combination with other regimens may reduce the relapse rate. We conducted CD22/CD19 CAR T-cells and blinatumoab combined with 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Study First Posted: 2025-05-22
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Study Start: 2025-06-01
• Primary Completion: 2029-06-01
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 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;
2. positive expression of CD19 and CD22 in peripheral blood or bone marrow primary cells detected by flow cytometry;
3. 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;
4. subjects aged 15-65 years (including 15 and 65 years), regardless of gender;
5. T-cell amplification test pass;
6. expected survival > 3 months.

Exclusion Criteria

1. patients with recurrence of only isolated extramedullary lesions;
2. combination of other malignant tumors;
3. previously treated with anti-CD19 or/and CD22 or/and CD3 therapies;
4. immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent;
5. uncontrolled active infections;
6. HIV infection;
7. active hepatitis B or hepatitis C infection;
8. history of severe tachyphylaxis to aminoglycoside antibiotics;
9. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years	It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive

Secondary Outcome Measures

Name	Time	Method
leukemia free survival	2 years	It is measured from the date of achievement of a remission after blinatumomab until the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.
Number of adverse events	2 years	Adverse events are evaluated with CTCAE V5.0 among Sandwich stratergy.