Targeted CD22/CD19 CAR-T Therapy for Consolidation in Standard-Risk B-ALL
ConditionB-cell Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorLiping Dou
About this trial
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.
Eligibility criteria
Qualifiers
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).
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.
Age between 18 and 85 years, regardless of sex.
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- CD22/CD19 Dual-Target CAR-T Cells
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Liping Dou
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Source ClinicalTrials.gov