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

September 1, 2026 updated by: Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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,CAR-T1) after standard induction and consolidation chemotherapy. Autologous stem cells mobilization and collection were performed 6-8 weeks after CAR-T infusion. Standard 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(CAR-T2). Patients were followed up and minimal residual diseases (MRD) was monitored by flow cytometry and second-generation gene sequencing of IgH rearrangement.

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CD22/CD19 CAR T and auto-HSCT sandwich strategy as consolidation therapy for B-ALL
Combination product: CD22/CD19 CAR T and auto-HSCT "sandwich" strategy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leukemia-free survival (LFS)
Time Frame: 2 years
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.
2 years
Measurable residual disease (MRD) negative rate and duration
Time Frame: 2 years
MRD is detected by flow cytometry (FC-MRD) and second-generation gene sequencing of IgH rearrangement (NGS-MRD) after the first CAR-T (CAR-T 1) . FC-MRD negative is defined as MRD<10-4 and NGS-MRD negative is defined as MRD<10-6.
2 years
Incidence of adverse events (AEs)
Time Frame: 2 years
AEs will be assessed according to the Common Terminology Criteria for Adverse Events 5.0 (CTCAE5.0) after the first CAR-T (CAR-T 1) .
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in 2-year LFS between the sandwich strategy treatment and external allo-HSCT control group
Time Frame: 2 years
2-year LFS and 95%CI will be calculated for the sandwich strategy treatment group and external allo-HSCT control group, Log-rank P value will be provided for group comparison result.
2 years
Difference in 2-year OS between the sandwich strategy treatment and external allo-HSCT control group
Time Frame: 2 years
2-year OS and 95%CI will be calculated for the sandwich strategy treatment group and external allo-HSCT control group, Log-rank P value will be provided for group comparison result.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2020

Primary Completion (Estimated)

July 21, 2027

Study Completion (Estimated)

July 21, 2039

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZCART02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Baseline characteristics of patients and outcome data.

IPD Sharing Time Frame

One year after the finishment of the study

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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