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

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with B-cell acute lymphoblastic leukemia (B-ALL), a type of cancer that affects the blood and bone marrow. The researchers are testing a combination of two types of CAR-T therapies (which use modified T-cells to attack cancer cells) along with a medication called blinatumomab, followed by a stem cell transplant. This "sandwich" strategy aims to strengthen the treatment and reduce the chances of the cancer coming back after the initial therapy.

To be eligible for this trial, participants need to be between 15 and 65 years old and have been diagnosed with B-ALL. They must have specific markers in their blood or bone marrow that the treatment targets and meet certain health requirements, like having good heart and lung function. However, patients with certain conditions, such as active infections or other serious health issues, will not be included. If you or a loved one qualify and decide to participate, you can expect close monitoring during the treatment process to ensure safety and effectiveness. This trial is currently not recruiting participants, but it represents a hopeful step toward improving outcomes for B-ALL patients.

Gender

ALL

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.