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

NCT ID: NCT06985498

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2029-09-01

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.

Conditions

Acute Lymphobkastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sandwich strategy

Group Type: EXPERIMENTAL

Sandwich stratergy

Intervention Type: COMBINATION_PRODUCT

The patients received blinatumoab after standard induction and consolidation chemotherapy. Autologous stem cells mobilization and collection were performed after blinatumomab. Auto-HSCT was proceeded after successful stem cell collection. CD22 and CD19 CAR-T cells were re-infused 2 days after stem cell reinfusion.

Interventions

Sandwich stratergy

The patients received blinatumoab after standard induction and consolidation chemotherapy. Autologous stem cells mobilization and collection were performed after blinatumomab. Auto-HSCT was proceeded after successful stem cell collection. CD22 and CD19 CAR-T cells were re-infused 2 days after stem cell reinfusion.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Sheng-Li Xue, MD

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sheng-Li Xue, M.D.

Role: CONTACT

slxue@suda.edu.cn

008613328008851

Other Identifiers

SZCART03

Identifier Type: -

Identifier Source: org_study_id