NCT05470777Active, not recruitingPhase 2
CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
Safety and Efficacy of CD22/CD19 CAR T-cells and Autologous HSCT Sandwich Strategy as Consolidation Therapy for B-cell Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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. The investigators first conducted CD22/CD19 CAR T-cells and 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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- First submitted
- 20 Jul 2022
- Start date
- 19 Jan 2020
- Primary completion date
- 21 Jul 2027
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- NCT number
- NCT05470777
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 37
- From 19 Jan 2020 to the primary completion date, 21 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- combination of other malignant tumors.
- 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.
Other
- patients with recurrence of only isolated extramedullary lesions.
Who the study is looking for
- 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.
Age in the registry: 15 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.