Acute Lymphobkastic LeukemiaPhase 2NCT06985498
Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL
A Phase 2 study testing Sandwich stratergy in people with Acute Lymphobkastic Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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
- Acute Lymphobkastic Leukemia
- What is being tested?
- Sandwich stratergy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Sep 2029
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Newly diagnosed patients with Philadelphia chromosome (Ph)-negative B-cell acute lymphoblastic leukemia (B-ALL) or Ph-positive B-ALL in the high-risk group who have received standard induction chemotherapy; Patients with relapsed/refractory or MRD-positive B-ALL after any course of treatment without a history of immunotherapies（i.e. CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or/and CD22 CAR-T cell therapy）, who also meet any of the following criteria: (a) Ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT). (b) Refuse allo-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 who are relapsed/refractory or MRD-positive following treatment with CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or/and CD22 CAR-T cell therapy or allo-HSCT;
- Patients with KMT2A rearrangement
- 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;
Show all 12Show fewer
- Presence of bacterial, fungal, viral, mycoplasmal, or other types of infection that the investigator determines to be difficult to control;
- Patients with history of hepatitis B (HBsAg positive)or prior hepatitis B infection (defined as HBcAb positive, HBsAg negative) are eligible for enrollment provided that HBV DNA testing by PCR is negative; these subjects must undergo monthly PCR testing for HBV DNA. Patients with positive HCV antibody serology are eligible for enrollment if HCV RNA testing by PCR is negative. Positive for Treponema pallidum antibody (TP-Ab). Positive for human immunodeficiency virus (HIV) antibody.
- History of severe immediate hypersensitivity reaction to any drug used in this study.
- 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.
- Pregnant or lactating women.
- Patients with primary immunodeficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Pre-Auto-HSCT Immunotherapy Combined With Auto-HSCT Followed by the CD22/CD19 CAR-T Sandwich Strategy for AYA and Adult 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. We conduct pre-auto-HSCT immunotherapy to achieve MRD negative remission, then perform auto-HSCT followed by CD22/CD19 CAR-T "sandwich " strategy in AYA and adult patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.
- Conditions
- Acute Lymphobkastic Leukemia
- Being tested
- Sandwich stratergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandwich stratergyCombination product
Newly diagnosed patients first receive standard chemotherapy as induction therapy, followed by immunotherapies as consolidation therapy. Relapsed or refractory patients directly receive immunotherapies. Minimal Residual Disease （MRD）was evaluated by multicolor flow cytometry （MFC-MRD）and next-generation sequencing of IgH rearrangement （NGS-MRD）after immunotherapies. Immunotherapies includes CD19-directed CD3 T-cell engager, inotuzumab ozogamicin (INO) and CD22/CD19 CAR-T cell. In principle, these three treatment options are administered sequentially. Once patients achieve dual negativity of MFC-MRD and NGS-MRD, no further immunotherapies are applied, and patients proceed to autologous stem cell mobilization and collection. Prior to autologous stem cell transplantation (Auto-HSCT), patients receive high-dose MTX for CNS prophylaxis. CD22/CD19 CAR-T cells are infused 2 days after stem cell infusion. Patients with ph positive and ph-like (ABL class) B-ALL require TKIs.
| Study group | Role | What they receive |
|---|---|---|
| Sandwich strategy | Experimental | Not described Receives: Combination Product: Sandwich stratergy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
It is measured from the date of the first course of immunotherapy to the date of death from any cause; patients 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 (2)
leukemia free survival
It is measured from the date of first achievement of a remission after any immunotherapy until the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.
Measured: 2 years
Number of adverse events
Adverse events are evaluated with CTCAE V5.0 among Sandwich stratergy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Why it stopped: According to the new regulations of China, newly launched clinical trials involved CAR-T cells must be apporved first by China National Center for Biotechology Development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphobkastic LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985498
- Sponsor's protocol ID
- SZCART03
- Status last verified
- May 2026
- First submitted
- 15 May 2025
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Pre-Auto-HSCT Immunotherapy Combined With Auto-HSCT Followed by the CD22/CD19 CAR-T Sandwich Strategy for AYA and Adult B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06985498
- Acronym / sponsor ID
- SZCART03
- Conditions
- Acute Lymphobkastic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: According to the new regulations of China, newly launched clinical trials involved CAR-T cells must be apporved first by China National Center for Biotechology Development.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. We conduct pre-auto-HSCT immunotherapy to achieve MRD negative remission, then perform auto-HSCT followed by CD22/CD19 CAR-T "sandwich " strategy in AYA and adult patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sandwich strategy | Experimental | Combination Product: Sandwich stratergy |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed patients with Philadelphia chromosome (Ph)-negative B-cell acute lymphoblastic leukemia (B-ALL) or Ph-positive B-ALL in the high-risk group who have received standard induction chemotherapy; Patients with relapsed/refractory or MRD-positive B-ALL after any course of treatment without a history of immunotherapies（i.e. CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or/and CD22 CAR-T cell therapy）, who also meet any of the following criteria: (a) Ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT). (b) Refuse allo-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;
Key exclusion criteria (12 listed)
- Patients who are relapsed/refractory or MRD-positive following treatment with CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or/and CD22 CAR-T cell therapy or allo-HSCT;
- Patients with KMT2A rearrangement
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sandwich stratergyNewly diagnosed patients first receive standard chemotherapy as induction therapy, followed by immunotherapies as consolidation therapy. Relapsed or refractory patients directly receive immunotherapies. Minimal Residual Disease （MRD）was evaluated by multicolor flow cytometry （MFC-MRD）and next-generation sequencing of IgH rearrangement （NGS-MRD）after immunotherapies. Immunotherapies includes CD19-directed CD3 T-cell engager, inotuzumab ozogamicin (INO) and CD22/CD19 CAR-T cell. In principle, these three treatment options are administered sequentially. Once patients achieve dual negativity of MFC-MRD and NGS-MRD, no further immunotherapies are applied, and patients proceed to autologous stem cell mobilization and collection. Prior to autologous stem cell transplantation (Auto-HSCT), patients receive high-dose MTX for CNS prophylaxis. CD22/CD19 CAR-T cells are infused 2 days after stem cell infusion. Patients with ph positive and ph-like (ABL class) B-ALL require TKIs. | Combination product | Sandwich strategy |
Primary outcome
Overall survival
Time frame: 2 years
It is measured from the date of the first course of immunotherapy to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive
2 secondary outcomes
leukemia free survival
Time frame: 2 years
Number of adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
Related trials for Acute Lymphobkastic Leukemia
Not yet recruitingPhase 2
Inotuzumab as Post-Trasplantation Therapy for Adult High-risk B-cell Precursor Acute Lymphoblastic Leukemia
Acute Lymphobkastic Leukemia, Adult
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
RecruitingObservational study
Establishment of a Novel Flow Cytometric Diagnostic Assay to Effectively Evaluate Immune Reconstitution After Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia
Acute Lymphobkastic Leukemia
Enrolling by invitationPhase 1/2
This is a Phase I/II Interventional, Open-label Treatment Study Designed to Evaluate the Safety and Efficacy of Anti CD 19/22 CAR- T Cells Immunotherapy for Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma.
Acute Lymphobkastic Leukemia, B Cell Lymphoma
Not yet recruitingPhase 1/2
A Phase 1/2 Study of T-cell Expressing a Novel CD19 Chimeric-Antigen Receptor (SHB-02-CD19) in Patients With CD19-expressing B-cell Malignancies
B Cell Malignancies, Acute Lymphobkastic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sandwich stratergy in people with Acute Lymphobkastic 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 12 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: paused, as of the sponsor's last update on 29 May 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?
Results are not available in the source record.
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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.