Exploratory Study of CD22/CD19 Dual-Target CAR-T Cell Therapy as Consolidation Treatment After First Remission in High-Risk B-Cell Acute Lymphoblastic Leukemia

NCT07575971 | Recruiting Phase 1 DMC

• 1 other identifier: S2025-1062-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, open-label, single-arm, prospective study will evaluate the safety, tolerability, and efficacy of CD22/CD19 dual-target CAR-T cell therapy as consolidation treatment in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) who have achieved first remission after standard induction therapy and consolidation chemotherapy. Approximately 30 patients will be enrolled. Participants will undergo screening, cell collection for CAR-T manufacturing, lymphodepleting chemotherapy, and subsequent CAR-T cell infusion, followed by scheduled safety and efficacy follow-up. Safety assessments will include monitoring for cytokine release syndrome, neurotoxicity, hematologic toxicity, organ toxicity, infections, and other adverse events. Efficacy assessments will include event-free survival, overall survival, progression-free survival, duration of response, relapse, and mortality. Exploratory analyses will assess CAR-T cell kinetic characteristics and clonal evolution after treatment.

Conditions

B-cell Acute Lymphoblastic Leukemia

Keywords

B-Cell Acute Lymphoblastic Leukemia; CAR-T Cell Therapy; Dual-Target CAR-T; CD19; CD22

Outcome Measures

Primary Outcomes (1)

• 1-year Event-Free Survival Rate (EFSR)

  The 1-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.

  1 years after CAR-T cell infusion

Secondary Outcomes (6)

• Overall Survival (OS)

  Up to 1 years after CAR-T cell infusion

• Time to Progression (TTP)

  Up to 1 years after CAR-T cell infusion

• Disease-Free Survival (DFS)

  Up to 1 years after CAR-T cell infusion

• Duration of Response (DOR)

  Up to 1 years after CAR-T cell infusion

• Relapse Rate

  Up to 1 years after CAR-T cell infusion

Study Arms (1)

CD22/CD19 Dual-Target CAR-T Cell Therapy

EXPERIMENTAL

Patients will receive CD22/CD19 dual-target CAR-T cell therapy following lymphodepleting chemotherapy.

Biological: CD22/CD19 Dual-Target CAR-T Cells

Interventions

CD22/CD19 Dual-Target CAR-T Cells BIOLOGICAL

Autologous CD22/CD19 dual-target chimeric antigen receptor T cells

CD22/CD19 Dual-Target CAR-T Cell Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• Patients who are eligible for enhanced consolidation therapy. Patients with high-risk disease defined as:
• High-risk group based on cytogenetic and molecular features, regardless of MRD status after consolidation; or Standard-risk group with persistent MRD positivity after two cycles of consolidation therapy, indicating a high risk of relapse.
• In addition, patients are unwilling or ineligible to allogeneic hematopoietic stem cell transplantation, and are planned to receive CAR-T cell therapy as consolidation treatment.
• Age between 18 and 85 years, regardless of sex.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Estimated life expectancy ≥3 months.
• Hemoglobin ≥60 g/L (transfusion allowed).
• Absolute neutrophil count ≥1,000/μL and platelet count ≥45,000/μL.
• 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.
• 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.

You may not qualify if:

• Patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), or with risk factors indicating the need for allogeneic hematopoietic stem cell transplantation (meeting any of the following), 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.
• Prior treatment with any CAR-T cell therapy or other genetically modified T-cell therapies.
• Known history of HIV infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.
• Non-disease-related hepatic or renal dysfunction defined as:
• ALT or AST \>3×ULN; Total bilirubin \>2×ULN; Creatinine clearance \<30 mL/min.
• History of significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, coronary intervention, unstable angina, or clinically significant arrhythmia.
• 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.
• History of severe immediate hypersensitivity reactions to study-related drugs, aminoglycosides, or biologic agents.
• Pregnant or breastfeeding women.
• Patients who are unable or unwilling to comply with study procedures or follow-up, or who have poor adherence as judged by the investigator.
• 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).

Sponsors & Collaborators

• Liping Dou: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

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

Li-Ping Dou, Dr.

CONTACT

+8613681207138; lipingruirui@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)