Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD22/CD19 CAR T and auto-HSCT "sandwich" strategy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD22/CD19 CAR T and auto-HSCT sandwich strategy as consolidation therapy for B-ALL
- interventionNames
- Combination Product: CD22/CD19 CAR T and auto-HSCT "sandwich" strategy
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 2 years
- description
- It is measured from the date of the first CAR-T (CAR-T 1) to the date of death from any cause; subjects not known to have died at last follow-up are censored on the date they were last known to be alive
Secondary outcomes (3)
- measure
- Leukemia-free survival (LFS)
- timeFrame
- 2 years
- description
- It is measured from the date of achievement of a remission after CAR-T 1 until the date of relapse from CR, or CRi, or death from any cause; subjects not known to have any of these events are censored on the date they were last examined.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDQian CS, Wang ZH, Li Z, Yao Z, Gong WJ, Wu YJ, Zhou HX, Xu MZ, Qiu Y, Xu SZ, Tan KW, Liu FT, Huang SM, Cao HY, Dai HP, Wu DP, Xue SL. A phase 2 trial of a "sandwich" strategy: Sequential CD22/CD19 chimeric antigen receptor T-cells therapy combined with autologous hematopoietic stem cell transplantation in patients with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia. Cancer. 2025 Nov 15;131(22):e70168. doi: 10.1002/cncr.70168. PMID 41199560