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B-cell Acute Lymphoblastic LeukemiaPhase 2NCT05470777

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

A Phase 2 study testing CD22/CD19 CAR T and auto-HSCT "sandwich" strategy in people with B-cell Acute Lymphoblastic Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 65 years
Conditions the study is for
B-cell Acute Lymphoblastic Leukemia
What is being tested?
CD22/CD19 CAR T and auto-HSCT "sandwich" strategy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
19 Jan 2020to 21 Jul 2039
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
CD22/CD19 CAR T and auto-HSCT "sandwich" strategy
Keywords
CD22/CD19 CAR-T, auto-HSCT
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD22/CD19 CAR T and auto-HSCT "sandwich" strategyCombination 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.

Study groups in NCT05470777
Study groupRoleWhat they receive
CD22/CD19 CAR T and auto-HSCT sandwich strategy as consolidation therapy for B-ALLExperimentalNot described
Receives: Combination Product: CD22/CD19 CAR T and auto-HSCT "sandwich" strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (3)

  1. Leukemia-free survival (LFS)

    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.

    Measured: 2 years

  2. Measurable residual disease (MRD) negative rate and duration

    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.

    Measured: 2 years

  3. Incidence of adverse events (AEs)

    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) .

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2022
  2. Study start19 Jan 2020
  3. Primary completion21 Jul 2027 (estimated)
  4. Study completion21 Jul 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05470777
Sponsor's protocol ID
SZCART02
Status last verified
Sep 2026
First submitted
20 Jul 2022
Last updated
2 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Baseline characteristics of patients and outcome data.

Publications

  • 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.

    PubMed 41199560

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD22/CD19 CAR T and auto-HSCT "sandwich" strategy in people with B-cell Acute Lymphoblastic Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05470777, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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