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

NCT05470777 | Recruiting Phase 2

• 1 other identifier: SZCART02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

B-cell Acute Lymphoblastic Leukemia

Keywords

CD22/CD19 CAR-T; auto-HSCT

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  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

  2 years

Secondary Outcomes (3)

• Leukemia-free survival (LFS)

  2 years

• Measurable residual disease (MRD) negative rate and duration

  2 years

• Incidence of adverse events (AEs)

  2 years

Other Outcomes (2)

• Difference in 2-year LFS between the sandwich strategy treatment and external allo-HSCT control group

  2 years

• Difference in 2-year OS between the sandwich strategy treatment and external allo-HSCT control group

  2 years

Study Arms (1)

CD22/CD19 CAR T and auto-HSCT sandwich strategy as consolidation therapy for B-ALL

EXPERIMENTAL

Combination Product: CD22/CD19 CAR T and auto-HSCT "sandwich" strategy

Interventions

CD22/CD19 CAR T and auto-HSCT "sandwich" strategy COMBINATION_PRODUCT

The patients received sequential infusion of CD22 and CD19 CAR-T cells (co-stimulatory molecule was 4-1BB and infusion dose was 5\*10\^6/kg respectively) after standard induction and consolidation chemotherapy. Autologous stem cells mobilization and collection were performed 6-8 weeks after CAR-T infusion. Modified BuCy as conditioning regimen for Auto-HSCT was used 4 weeks after successful stem cell collection. CD22 and CD19 CAR-T cells were re-infused 2 days after Auto-HSCT. Patients were followed up and minimal residual diseases (MRD) was monitored by flow cytometry and second-generation gene sequencing of IgH rearrangement.

CD22/CD19 CAR T and auto-HSCT sandwich strategy as consolidation therapy for B-ALL

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• National Natural Science Foundation of China(Grant No. 81970138): collaborator
• Jiangsu Province Natural Science Foundation of China (Grant No. BK20210091): collaborator
• Jining Medical University: collaborator
• The Second People's Hospital of Huai'an: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• Northern Jiangsu People's Hospital: collaborator
• Affiliated Hospital of Nantong University: collaborator
• Suzhou Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Related Publications (1)

• Qian 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 DERIVED

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Sheng-Li Xue, M.D.

CONTACT

+86 512 67781139; slxue@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: January 19, 2020
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): July 21, 2039
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: One year after the finishment of the study
• Access Criteria: Clinical researchers around the world are all able to access the IPD and supporting information after achieving the authorization of the sponsor. They could be able to get IPD details by visiting ResMan system.

Locations

CN (1)