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

Soochow University

Status and phase: Begins enrollment in 3 months; Phase 2

Conditions: Acute Lymphobkastic Leukemia

Treatments: Combination Product: Sandwich stratergy

Study type: Interventional

Funder types: Other

Identifiers

NCT06985498

SZCART03

Details and patient eligibility

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. 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Sandwich strategy

Experimental group

Treatment:

Combination Product: Sandwich stratergy