Combination of CAR-T therapy and stem cell transplant for B-cell leukemia

Safety and Efficacy of CD22/CD19 CAR T-cells and Autologous HSCT Sandwich Strategy as Consolidation Therapy for B-cell Acute Lymphoblastic Leukemia

This study is testing a new treatment for B-cell leukemia that combines special immune cells with a stem cell transplant to see if it helps patients stay cancer-free longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 15 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: CAR-T, CAR T, Chimeric antigen receptor, chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05470777 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel treatment approach for B-cell acute lymphoblastic leukemia (B-ALL) that combines CD22 and CD19 chimeric antigen receptor T-cell (CAR-T) therapy with autologous hematopoietic stem cell transplantation (auto-HSCT). Patients will receive sequential infusions of CAR-T cells after standard chemotherapy, followed by stem cell collection and conditioning before re-infusion of CAR-T cells post-transplant. The primary aim is to assess the safety and efficacy of this 'sandwich' strategy in reducing relapse rates in B-ALL patients. Monitoring of minimal residual disease will be conducted to evaluate treatment effectiveness.

Who should consider this trial

Good fit: Ideal candidates are patients aged 15-65 with B-ALL who express CD19 and CD22 and either lack a suitable allogeneic donor or refuse allogeneic HSCT.

Not a fit: Patients with isolated extramedullary lesions or those who have previously received anti-CD19 or CD22 therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce relapse rates in patients with B-ALL, improving long-term outcomes.

How similar studies have performed: While CAR-T therapy has shown promise in treating B-ALL, this specific combination approach is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Sheng-Li Xue, M.D.

Conditions B-cell Acute Lymphoblastic Leukemia; CD22/CD19 CAR-T; auto-HSCT