Targeted CD22/CD19 CAR-T Therapy for Consolidation in Standard-Risk B-ALL

May 4, 2026 updated by: Liping Dou

An Exploratory Study on Targeted CD22/CD19 Chimeric Antigen Receptor (CAR)-T Cell Immunotherapy for Enhanced Consolidation Therapy of Standard-risk B-cell Acute Lymphoblastic Leukemia

This is a single-center, open-label, single-arm prospective study designed to evaluate the safety, tolerability, and efficacy of dual-target CD22/CD19 chimeric antigen receptor (CAR)-T cell therapy as consolidation treatment in patients with standard-risk B-cell acute lymphoblastic leukemia (B-ALL) in remission. Eligible patients will undergo leukapheresis for CAR-T cell manufacturing, followed by lymphodepleting chemotherapy and CAR-T cell infusion. Patients will be closely monitored for safety, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, and infections. Efficacy endpoints include event-free survival (EFS), overall survival (OS), progression-free survival (PFS), relapse rate, and mortality. Exploratory analyses will assess CAR-T cell expansion kinetics and clonal evolution. The total follow-up duration is planned to be 2 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Recruiting
        • Chinese PLA General Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who have provided written informed consent and are willing and able to comply with study procedures, including scheduled visits, treatment, laboratory tests, and other study-related assessments.
  2. Patients with cytologically or histologically confirmed B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL) according to WHO 2022 criteria, with CD19-positive and/or CD22-positive disease. Patients must have achieved first morphological complete remission (CR1; bone marrow blasts <5%) after standard induction chemotherapy. Patients may or may not have achieved deep remission, defined as minimal residual disease (MRD) negativity assessed by flow cytometry and/or molecular methods (e.g., quantitative PCR or next-generation sequencing).
  3. Adult patients with standard-risk B-cell acute lymphoblastic leukemia , as defined by cytogenetic and molecular risk stratification and without high-risk features, who have achieved complete remission (CR) after treatment, received two cycles of long-course intensive consolidation chemotherapy, maintained sustained bone marrow MRD negativity by multiparameter flow cytometry (MFC) and sustained molecular MRD negativity by real-time quantitative polymerase chain reaction (RT-qPCR) or next-generation sequencing (NGS), are not considered to require allogeneic hematopoietic stem cell transplantation (allo-HSCT) for consolidation, and refuse or are ineligible to receive CD19/CD3 bispecific antibody therapy (e.g., blinatumomab), and are therefore planned to receive CAR-T cell immunotherapy as enhanced consolidation therapy followed by long-term maintenance treatment.
  4. Age between 18 and 85 years, regardless of sex.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  6. Estimated life expectancy ≥3 months.
  7. Hemoglobin ≥60 g/L (transfusion allowed).
  8. Absolute neutrophil count ≥1,000/μL and platelet count ≥45,000/μL.
  9. Adequate organ function, defined as:

Total bilirubin ≤1.5 × upper limit of normal (ULN) (except Gilbert's syndrome); ALT and AST ≤2.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) ≥50%, no clinically significant arrhythmia, and no pericardial effusion; Baseline oxygen saturation >92% on room air; No clinically significant pleural effusion.

10. Subjects of reproductive potential must agree to use effective contraception from enrollment until at least 6 months after completion of the study. Subjects who are pregnant or suspected to be pregnant must notify the investigator immediately.

Exclusion Criteria:

  1. Patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), or with risk factors indicating the need for allogeneic hematopoietic stem cell transplantation, who are planned to receive allogeneic hematopoietic stem cell transplantation or CD19/CD3 bispecific antibody (blinatumomab) therapy and refuse CAR-T cell immunotherapy as consolidation treatment, including any of the following conditions:

    ① Early relapse within 6 months after achieving first complete remission;

    ② Primary refractory disease, defined as failure to achieve first morphological complete remission after two cycles of standard first-line induction chemotherapy;

    ③ Failure to achieve complete remission or relapse after first-line or multiple lines of salvage chemotherapy;

    ④ Relapse after allogeneic hematopoietic stem cell transplantation;

    ⑤ Persistent MRD positivity with a high risk of relapse.

  2. Prior treatment with any CAR-T cell therapy or other genetically modified T-cell therapies.

  3. Known history of HIV infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.

    (Active HBV infection is defined as: HBV DNA ≥2000 IU/mL, ALT ≥2×ULN, and exclusion of other causes of hepatitis.)

  4. Non-disease-related hepatic or renal dysfunction defined as:

    ALT or AST >3×ULN; Total bilirubin >2×ULN; Creatinine clearance <30 mL/min.

  5. History of significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, coronary intervention, unstable angina, or clinically significant arrhythmia.
  6. Other severe or uncontrolled medical conditions that may interfere with study participation or outcomes, including but not limited to uncontrolled diabetes, severe gastrointestinal disease, severe cardiopulmonary disease, autoimmune disease, immunodeficiency, or uncontrolled infections.
  7. History of severe immediate hypersensitivity reactions to study-related drugs, aminoglycosides, or biologic agents.
  8. Pregnant or breastfeeding women.
  9. Patients who are unable or unwilling to comply with study procedures or follow-up, or who have poor adherence as judged by the investigator.
  10. History of other malignancies unless disease-free for at least 3 years without active treatment (except for adequately treated non-melanoma skin cancer or carcinoma in situ).
  11. Receipt of live vaccines within 6 weeks prior to initiation of lymphodepleting chemotherapy.
  12. Major surgery within 14 days prior to enrollment or planned major surgery during the study period.
  13. Any other condition that, in the investigator's judgment, may increase risk, interfere with study results, or make the patient unsuitable for the study.

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 Dual-Target CAR-T Cell Therapy
Patients will receive CD22/CD19 dual-target CAR-T cell therapy following lymphodepleting chemotherapy.
Biological: CD22/CD19 Dual-Target CAR-T Cells
Autologous CD22/CD19 dual-target chimeric antigen receptor T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year Event-Free Survival Rate (EFSR)
Time Frame: 2 years after CAR-T cell infusion
The 2-year event-free survival rate after CD22/CD19 CAR-T cell therapy used as enhanced consolidation treatment in high-risk B-cell acute lymphoblastic leukemia.
2 years after CAR-T cell infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 2 years after CAR-T cell infusion
Up to 2 years after CAR-T cell infusion
Progression-Free Survival (PFS)
Time Frame: Up to 2 years after CAR-T cell infusion
Up to 2 years after CAR-T cell infusion
Time to Progression (TTP)
Time Frame: Up to 2 years after CAR-T cell infusion
Up to 2 years after CAR-T cell infusion
Disease-Free Survival (DFS)
Time Frame: Up to 2 years after CAR-T cell infusion
Up to 2 years after CAR-T cell infusion
Duration of Response (DOR)
Time Frame: Up to 2 years after CAR-T cell infusion
Up to 2 years after CAR-T cell infusion
Relapse Rate
Time Frame: Up to 2 years after CAR-T cell infusion
Up to 2 years after CAR-T cell infusion
Mortality Rate
Time Frame: Up to 2 years after CAR-T cell infusion
Up to 2 years after CAR-T cell infusion

Collaborators and Investigators

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

Sponsor

Liping Dou

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 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2025-1061-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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